Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-29 @ 11:30 AM
Study NCT ID:
NCT05107492
Status:
COMPLETED
Last Update Posted:
2024-03-21
First Post:
2021-11-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Pharmacokinetics, Safety and Tolerability of Single Dose of PF-06480605 in Chinese Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 to Day 114', 'description': 'SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'PF-06480605 450mg', 'description': 'Participants received a single subcutaneous dose of PF-06480605 450 mg on Day 1.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 7, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received matching placebo on Day 1.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Tongue ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'White blood cells urine positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Observed Concentration (Cmax) of PF-06480605', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06480605 450mg', 'description': 'Participants who received PF-06480605 450mg'}], 'classes': [{'categories': [{'measurements': [{'value': '41530', 'spread': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1', 'description': 'Cmax is the maximum observed plasma concentration.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this outcome measure (OM) was not planned to be collected and analyzed for placebo arm.'}, {'type': 'PRIMARY', 'title': 'Time for Cmax (Tmax) of PF-06480605', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06480605 450mg', 'description': 'Participants who received PF-06480605 450mg'}], 'classes': [{'categories': [{'measurements': [{'value': '96.00', 'groupId': 'OG000', 'lowerLimit': '95.9', 'upperLimit': '335'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1', 'description': 'Tmax is the time for Cmax.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this OM was not planned to be collected and analyzed for placebo arm.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve From Time 0 to End of Dosing Interval (AUC14day) of PF-06480605', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06480605 450mg', 'description': 'Participants who received PF-06480605 450mg'}], 'classes': [{'categories': [{'measurements': [{'value': '11600000', 'spread': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, and 336 hours post dose on Day 1', 'description': 'AUC14day is area under the curve from time 0 to end of dosing interval (Day 14, 336 hours).', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this OM was not planned to be collected and analyzed for placebo arm.'}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06480605', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06480605 450mg', 'description': 'Participants who received PF-06480605 450mg'}], 'classes': [{'categories': [{'measurements': [{'value': '31390000', 'spread': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1', 'description': 'AUCinf is area under the plasma concentration time profile from time 0 extrapolated to infinite time.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this OM was not planned to be collected and analyzed for placebo arm.'}, {'type': 'PRIMARY', 'title': 'Terminal Half-life (t1/2) of PF-06480605', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06480605 450mg', 'description': 'Participants who received PF-06480605 450mg'}], 'classes': [{'categories': [{'measurements': [{'value': '306.4', 'spread': '134.49', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1', 'description': 't1/2 is the terminal half-life (time required for the plasma concentration to decline by 50%)', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this OM was not planned to be collected and analyzed for placebo arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06480605 450mg', 'description': 'Participants who received PF-06480605 450mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo'}], 'classes': [{'title': 'All-causality TEAEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related TEAEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Day 114', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and before the end of study (up to follow-up visits). AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all randomized participants who received at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06480605 450mg', 'description': 'Participants who received PF-06480605 450mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline (BL) to Day 114', 'description': 'Vital signs abnormalities included: supine diastolic blood pressure (BP) increase and decrease from BL of \\>=20mmHg or absolute value \\<50mmHg; systolic BP increase and decrease from BL of \\>=30mmHg or absolute value \\<90mmHg; pulse rate \\<40 or \\>120bpm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all randomized participants who received at least 1 dose of study intervention. Participants with evaluable vital signs data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change From Baseline in Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06480605 450mg', 'description': 'Participants who received PF-06480605 450mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From BL to Day 114', 'description': 'ECG assessments included PR, QT, and QTc intervals and QRS complex. ECG abnormalities included PR interval BL \\>200msec and max \\>=25% increase from BL, or BL \\<=200msec and max \\>=50% increase from BL, or absolute value \\>=300msec; QRS interval percent change from BL \\>=50% or absolute value \\>=140msec, QTcF change from BL \\>=30msec, or absolute value \\>450msec.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all randomized participants who received at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06480605 450mg', 'description': 'Participants who received PF-06480605 450mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo'}], 'classes': [{'title': 'Neutrophils > 1.2 x Upper Limit of Normal (ULN)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Basophils > 1.2 x ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes > 1.2 x ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase > 3.0 x ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Ketones >=1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From BL to Day 114', 'description': "Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion. Laboratory test abnormalities reported by at least 1 participant are reported in this outcome measure.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all randomized participants who received at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06480605', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06480605 450mg', 'description': 'Participants who received PF-06480605 450mg'}], 'classes': [{'categories': [{'measurements': [{'value': '29990000', 'spread': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1', 'description': 'AUClast is area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this OM was not planned to be collected and analyzed for placebo arm.'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution (Vz/F) of PF-06480605', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06480605 450mg', 'description': 'Participants who received PF-06480605 450mg'}], 'classes': [{'categories': [{'measurements': [{'value': '5.839', 'spread': '42', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1', 'description': 'Vz/F is the apparent volume of distribution, defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.', 'unitOfMeasure': 'liter (L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this OM was not planned to be collected and analyzed for placebo arm.'}, {'type': 'SECONDARY', 'title': 'Apparent Oral Clearance (CL/F) of PF-06480605', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06480605 450mg', 'description': 'Participants who received PF-06480605 450mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01434', 'spread': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1', 'description': 'CL/F is the apparent oral clearance, which is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.', 'unitOfMeasure': 'liter per hour (L/hr)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all randomized participants who received at least 1 dose of study intervention and for whom at least 1 of the PK parameters of interest was calculated. Data for this OM was not planned to be collected and analyzed for placebo arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positivie Anti-drug Antibody (ADA) Against PF-06480605', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06480605 450mg', 'description': 'Participants who received PF-06480605 450mg'}], 'classes': [{'title': 'Day 1 (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Day 114', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'On Days 1 (prior to dose), 15, 29, 57, 85 and 114', 'description': 'Summary of ADA incidence by visit is presented. ADA positive was defined as titer \\>=60.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The immunogenicity analysis set included all randomized participants who received at least 1 dose of study intervention with at least 1 post-treatment anti-drug (PF-06480605) antibody determination. Number analyzed = Number of participants with observed ADA results at the specific visit.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Neutralizing Antibody (NAb) Against PF-06480605', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06480605 450mg', 'description': 'Participants who received PF-06480605 450mg'}], 'classes': [{'title': 'Day 1 (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Day 114', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'On Days 1 (prior to dose), 15, 29, 57, 85 and 114', 'description': 'Summary of NAb incidence by visit is presented. NAb positive was defined as titer \\>=5. ADA-positive participants (defined as titer \\>=60) were analyzed for NAb.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The immunogenicity analysis set included all randomized participants who received at least 1 dose of study intervention with at least 1 post-treatment anti-drug (PF-06480605) antibody determination. Number of Participants Analyzed = the total number of participants who had ADA-positive results in this study. Number Analyzed = Number of participants who had ADA-positive results at the specific visit.'}, {'type': 'SECONDARY', 'title': 'Total Soluble Tumor Necrosis Factor Like Ligand 1A (sTL1A) Protein Concentration in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06480605 450mg', 'description': 'Participants who received PF-06480605 450mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants who received placebo'}], 'classes': [{'title': 'Day 1 (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.7', 'spread': '15.73', 'groupId': 'OG000'}, {'value': '89.7', 'spread': '17.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '314.1', 'spread': '75.62', 'groupId': 'OG000'}, {'value': '110.1', 'spread': '23.46', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1470.3', 'spread': '409.89', 'groupId': 'OG000'}, {'value': '97.2', 'spread': '14.39', 'groupId': 'OG001'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3817.8', 'spread': '1172.54', 'groupId': 'OG000'}, {'value': '116.0', 'spread': '25.98', 'groupId': 'OG001'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3319.2', 'spread': '2096.47', 'groupId': 'OG000'}, {'value': '109.6', 'spread': '13.72', 'groupId': 'OG001'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2126.0', 'spread': '2473.33', 'groupId': 'OG000'}, {'value': '123.0', 'spread': '22.61', 'groupId': 'OG001'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '571.7', 'spread': '548.71', 'groupId': 'OG000'}, {'value': '110.9', 'spread': '22.86', 'groupId': 'OG001'}]}]}, {'title': 'Day 114', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '597.6', 'spread': '404.22', 'groupId': 'OG000'}, {'value': '108.7', 'spread': '8.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'On Days 1 (prior to dose), 2, 5, 15, 29, 57, 85 and 114', 'description': 'The total sTL1A protein concentration in serum is summarized by time.', 'unitOfMeasure': 'picogram per milliliter (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacodynamic (PD) analysis set included all randomized participants who had at least 1 PD assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-06480605 450mg', 'description': 'Participants received a single subcutaneous dose of PF-06480605 450 mg on Day 1.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received matching placebo on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'comment': 'Completion of the entire study including the follow-up phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 12 Chinese healthy adult participants were enrolled, with 9 assigned to PF-06480605 450mg group and 3 to placebo.', 'preAssignmentDetails': 'This was a placebo-controlled study of PF-06480605 following 450 mg and 150 mg (if needed) in Chinese healthy adults. Optional 150 mg cohort was not conducted as pharmacokinetic (PK) data of 450mg group did not suggest ethnic difference with previous Western/Japanese studies (by comparing dose-normalized mean exposures/dose-normalized mean concentrations profiles).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-06480605 450mg', 'description': 'Participants received a single subcutaneous dose of PF-06480605 450 mg on Day 1.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received matching placebo on Day 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '39'}, {'value': '28', 'groupId': 'BG001', 'lowerLimit': '23', 'upperLimit': '40'}, {'value': '34', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '40'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '<18', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '18-44', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': '45-64', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '>=65', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian (Chinese)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants who received a dose of study intervention'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-29', 'size': 8962433, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-30T14:42', 'hasProtocol': True}, {'date': '2022-04-25', 'size': 1978345, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-30T14:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-14', 'studyFirstSubmitDate': '2021-11-03', 'resultsFirstSubmitDate': '2023-03-30', 'studyFirstSubmitQcDate': '2021-11-03', 'lastUpdatePostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-14', 'studyFirstPostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Concentration (Cmax) of PF-06480605', 'timeFrame': 'At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1', 'description': 'Cmax is the maximum observed plasma concentration.'}, {'measure': 'Time for Cmax (Tmax) of PF-06480605', 'timeFrame': 'At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1', 'description': 'Tmax is the time for Cmax.'}, {'measure': 'Area Under the Curve From Time 0 to End of Dosing Interval (AUC14day) of PF-06480605', 'timeFrame': 'At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, and 336 hours post dose on Day 1', 'description': 'AUC14day is area under the curve from time 0 to end of dosing interval (Day 14, 336 hours).'}, {'measure': 'Area Under the Plasma Concentration Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06480605', 'timeFrame': 'At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1', 'description': 'AUCinf is area under the plasma concentration time profile from time 0 extrapolated to infinite time.'}, {'measure': 'Terminal Half-life (t1/2) of PF-06480605', 'timeFrame': 'At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1', 'description': 't1/2 is the terminal half-life (time required for the plasma concentration to decline by 50%)'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Day 1 to Day 114', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and before the end of study (up to follow-up visits). AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.'}, {'measure': 'Number of Participants With Change From Baseline in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria', 'timeFrame': 'From Baseline (BL) to Day 114', 'description': 'Vital signs abnormalities included: supine diastolic blood pressure (BP) increase and decrease from BL of \\>=20mmHg or absolute value \\<50mmHg; systolic BP increase and decrease from BL of \\>=30mmHg or absolute value \\<90mmHg; pulse rate \\<40 or \\>120bpm.'}, {'measure': 'Number of Participants With Change From Baseline in Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria', 'timeFrame': 'From BL to Day 114', 'description': 'ECG assessments included PR, QT, and QTc intervals and QRS complex. ECG abnormalities included PR interval BL \\>200msec and max \\>=25% increase from BL, or BL \\<=200msec and max \\>=50% increase from BL, or absolute value \\>=300msec; QRS interval percent change from BL \\>=50% or absolute value \\>=140msec, QTcF change from BL \\>=30msec, or absolute value \\>450msec.'}, {'measure': 'Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)', 'timeFrame': 'From BL to Day 114', 'description': "Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion. Laboratory test abnormalities reported by at least 1 participant are reported in this outcome measure."}, {'measure': 'Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06480605', 'timeFrame': 'At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1', 'description': 'AUClast is area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration'}, {'measure': 'Apparent Volume of Distribution (Vz/F) of PF-06480605', 'timeFrame': 'At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1', 'description': 'Vz/F is the apparent volume of distribution, defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.'}, {'measure': 'Apparent Oral Clearance (CL/F) of PF-06480605', 'timeFrame': 'At 0 (prior to dose), 2, 6, 24, 48, 72, 96, 216, 336, 672, 1008, 1344, 2016, and 2712 hours post dose on Day 1', 'description': 'CL/F is the apparent oral clearance, which is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.'}, {'measure': 'Number of Participants With Positivie Anti-drug Antibody (ADA) Against PF-06480605', 'timeFrame': 'On Days 1 (prior to dose), 15, 29, 57, 85 and 114', 'description': 'Summary of ADA incidence by visit is presented. ADA positive was defined as titer \\>=60.'}, {'measure': 'Number of Participants With Neutralizing Antibody (NAb) Against PF-06480605', 'timeFrame': 'On Days 1 (prior to dose), 15, 29, 57, 85 and 114', 'description': 'Summary of NAb incidence by visit is presented. NAb positive was defined as titer \\>=5. ADA-positive participants (defined as titer \\>=60) were analyzed for NAb.'}, {'measure': 'Total Soluble Tumor Necrosis Factor Like Ligand 1A (sTL1A) Protein Concentration in Serum', 'timeFrame': 'On Days 1 (prior to dose), 2, 5, 15, 29, 57, 85 and 114', 'description': 'The total sTL1A protein concentration in serum is summarized by time.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IBD', 'PK'], 'conditions': ['Inflammatory Bowel Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B7541013', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, single-center, randomized, double-blind, third-party open (ie, participant blind, investigator blind and sponsor open), placebo controlled study to investigate PK, safety, tolerability, immunogenicity, and PD of PF 06480605 following a single subcutaneous dose of PF-06480605 450 mg and 150 mg (if needed) in Chinese healthy adult participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female participants must be 18 to 45 years of age, inclusive, at the time of signing the ICD.\n* Male and female Chinese participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital sign and 12-lead ECG\n* BMI of 19 to 27 kg/m2; and a total body weight \\>50 kg.\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).\n* History of HIV infection, hepatitis B, hepatitis C or syphilis; positive testing for HIV, hepatitis B, HCVAb or serological reaction of syphilis.\n* History of allergic or anaphylactic reaction to a therapeutic drug.\n* History of recent active infections within 28 days prior to the screening visit.\n* Participants with a fever within 48 hours prior to dosing.\n* History of TB or active or latent or inadequately treated infection.\n* Recent exposure to live vaccines within 28 days of the screening visit.\n* A positive pregnancy test.'}, 'identificationModule': {'nctId': 'NCT05107492', 'briefTitle': 'Evaluation of the Pharmacokinetics, Safety and Tolerability of Single Dose of PF-06480605 in Chinese Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY OPEN, PLACEBO-CONTROLLED STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY FOLLOWING SINGLE SUBCUTANEOUS DOSE OF PF-06480605 IN CHINESE HEALTHY PARTICIPANTS', 'orgStudyIdInfo': {'id': 'B7541013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': '12 participants will be randomly assigned at an allocation ratio of 3:1 to the active treatment 450mg and placebo arms.', 'interventionNames': ['Drug: 450mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': '12 participants will be randomly assigned at an allocation ratio of 3:1 to the active treatment 150mg and placebo arms.', 'interventionNames': ['Drug: 150mg', 'Drug: Placebo']}], 'interventions': [{'name': '450mg', 'type': 'DRUG', 'description': 'following a single subcutaneous dose of PF-06480605 450 mg', 'armGroupLabels': ['Cohort 1']}, {'name': '150mg', 'type': 'DRUG', 'description': 'following a single subcutaneous dose of PF-06480605 150 mg', 'armGroupLabels': ['Cohort 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'following a single subcutaneous dose of placebo', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}