Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-30 @ 4:44 PM
Study NCT ID:
NCT04503603
Status:
COMPLETED
Last Update Posted:
2022-03-07
First Post:
2020-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered Intravenously in Healthy Adult Volunteer Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000596550', 'term': 'lanadelumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'TrialDisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Study Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of study treatment up to the end of study (Day 112)', 'eventGroups': [{'id': 'EG000', 'title': 'Lanadelumab 300 mg', 'description': 'Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 7, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo (normal saline) IV infusion on Day 1 followed by a second dose on Day 4.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lanadelumab 300 mg', 'description': 'Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo (normal saline) IV infusion on Day 1 followed by a second dose on Day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study treatment up to the end of study (Day 112)', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study that did not necessarily have a causal relationship with the treatment. TEAEs were events that occurred on or after the date and time of administration of the first dose of study medication. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set consisted of all participants who had started at least 1 dose of lanadelumab or placebo.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lanadelumab 300 mg', 'description': 'Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo (normal saline) IV infusion on Day 1 followed by a second dose on Day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study treatment up to the end of study (Day 112)', 'description': 'Clinical laboratory assessment included hematology, clinical chemistry, coagulation, and urinalysis. Any changes in clinical laboratory results that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant change from baseline in laboratory values were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set consisted of all participants who had started at least 1 dose of lanadelumab or placebo.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Change From Baseline in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lanadelumab 300 mg', 'description': 'Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo (normal saline) IV infusion on Day 1 followed by a second dose on Day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study treatment up to the end of study (Day 112)', 'description': 'Vital signs included blood pressure (systolic and diastolic), heart rate, and body temperature (oral). Any changes in vital signs that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant change from baseline in vital signs were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set consisted of all participants who had started at least 1 dose of lanadelumab or placebo.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lanadelumab 300 mg', 'description': 'Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo (normal saline) IV infusion on Day 1 followed by a second dose on Day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study treatment up to the end of study (Day 112)', 'description': '12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. Any changes in ECG parameters that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set consisted of all participants who had started at least 1 dose of lanadelumab or placebo.'}, {'type': 'PRIMARY', 'title': 'AUC0-last: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration for Lanadelumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lanadelumab 300 mg', 'description': 'Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '32955', 'spread': '10.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (Day 1) up to 2664 hours post-dose', 'description': 'AUC0-last for lanadelumab was reported.', 'unitOfMeasure': 'hour*microgram per milliliter (h*mcg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.'}, {'type': 'PRIMARY', 'title': 'AUC0-inf: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity for Lanadelumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lanadelumab 300 mg', 'description': 'Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '33305', 'spread': '10.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (Day 1) up to 2664 hours post-dose', 'description': 'AUC0-inf for lanadelumab was reported.', 'unitOfMeasure': 'h*mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.'}, {'type': 'PRIMARY', 'title': 'Cmax1: Maximum Observed Plasma Concentration Following the First IV Dose for Lanadelumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lanadelumab 300 mg', 'description': 'Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.6', 'spread': '16.1', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (Day 1) up to 2664 hours post-dose', 'description': 'Cmax1 following the first IV dose for lanadelumab was reported.', 'unitOfMeasure': 'microgram per milliliter (mcg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.'}, {'type': 'PRIMARY', 'title': 'Cmax2: Maximum Observed Plasma Concentration Following the Second IV Dose for Lanadelumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lanadelumab 300 mg', 'description': 'Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '120', 'spread': '20.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (Day 4) up to 2592 hours post-dose', 'description': 'Cmax2 following the second IV dose for lanadelumab was reported.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.'}, {'type': 'PRIMARY', 'title': 'Tmax1: Minimum Observed Time to Reach the First Cmax1 for Lanadelumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lanadelumab 300 mg', 'description': 'Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.01', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '4.01'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose (Day 1) up to 2664 hours post-dose', 'description': 'Tmax1 following the first IV dose for lanadelumab was reported.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.'}, {'type': 'PRIMARY', 'title': 'Tmax2: Minimum Observed Time to Reach the Second Cmax2 for Lanadelumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lanadelumab 300 mg', 'description': 'Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.03', 'groupId': 'OG000', 'lowerLimit': '72.92', 'upperLimit': '76.02'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose (Day 4) up to 2592 hours post-dose', 'description': 'Tmax2 following the second IV dose for lanadelumab was reported.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.'}, {'type': 'PRIMARY', 'title': 'Terminal Half-Life (T1/2) of Lanadelumab in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lanadelumab 300 mg', 'description': 'Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.3', 'groupId': 'OG000', 'lowerLimit': '13.7', 'upperLimit': '19.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose (Day 1) up to 2664 hours post-dose', 'description': 'T1/2 is defined as the time required for the concentration of the drug to reach half of its original value. T1/2 for lanadelumab was reported.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.'}, {'type': 'PRIMARY', 'title': 'Clearance (CL) of Lanadelumab in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lanadelumab 300 mg', 'description': 'Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.1', 'spread': '10.4', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (Day 1) up to 2664 hours post-dose', 'description': 'Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body. CL for lanadelumab was reported.', 'unitOfMeasure': 'milliliter per hour (mL/h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.'}, {'type': 'PRIMARY', 'title': 'Vss: Volume of Distribution at Steady State in Plasma for Lanadelumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lanadelumab 300 mg', 'description': 'Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '8070', 'spread': '19.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (Day 1) up to 2664 hours post-dose', 'description': 'Volume of distribution is 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. Vss for lanadelumab was reported.', 'unitOfMeasure': 'milliliter (mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.'}, {'type': 'PRIMARY', 'title': 'First Order Elimination Rate Constant Associated With the Terminal (Log-linear) Portion of the Curve (Lambda z) of Lanadelumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lanadelumab 300 mg', 'description': 'Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.90', 'spread': '31.0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (Day 1) up to 2664 hours post-dose', 'description': 'Lambda z of Lanadelumab was reported.', 'unitOfMeasure': 'Per hour (/h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set consisted of all participants who received at least one dose of the study drug and had at least one evaluable PK concentration post-dose.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lanadelumab 300 mg', 'description': 'Participants received a single dose of lanadelumab 300 mg intravenous (IV) infusion on Day 1 followed by a second dose on Day 4.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received a single dose of lanadelumab matching placebo (normal saline) IV infusion on Day 1 followed by a second dose on Day 4.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at 1 investigative site in the United States between 10 August 2020 (first participant first visit) and 23 December 2020 (last participant last visit).', 'preAssignmentDetails': 'A total of 12 healthy participants were enrolled and randomized to receive lanadelumab 300 milligrams (mg) or matching placebo in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lanadelumab 300 mg', 'description': 'Participants received a single dose of lanadelumab 300 mg IV infusion on Day 1 followed by a second dose on Day 4.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received a single dose of placebo (normal saline) IV infusion on Day 1 followed by a second dose on Day 4.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.3', 'spread': '11.73', 'groupId': 'BG000'}, {'value': '42.0', 'spread': '10.44', 'groupId': 'BG001'}, {'value': '36.3', 'spread': '11.48', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The safety analysis set consisted of all participants who had started at least 1 dose of lanadelumab or placebo.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-16', 'size': 2270116, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-12-14T10:45', 'hasProtocol': True}, {'date': '2020-09-21', 'size': 766469, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-12-14T10:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-14', 'studyFirstSubmitDate': '2020-08-05', 'resultsFirstSubmitDate': '2021-12-14', 'studyFirstSubmitQcDate': '2020-08-05', 'lastUpdatePostDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-14', 'studyFirstPostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'From the first dose of study treatment up to the end of study (Day 112)', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study that did not necessarily have a causal relationship with the treatment. TEAEs were events that occurred on or after the date and time of administration of the first dose of study medication. TEAEs included both serious TEAEs and non-serious TEAEs. Number of participants with TEAEs were reported.'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters', 'timeFrame': 'From the first dose of study treatment up to the end of study (Day 112)', 'description': 'Clinical laboratory assessment included hematology, clinical chemistry, coagulation, and urinalysis. Any changes in clinical laboratory results that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant change from baseline in laboratory values were reported.'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in Vital Signs', 'timeFrame': 'From the first dose of study treatment up to the end of study (Day 112)', 'description': 'Vital signs included blood pressure (systolic and diastolic), heart rate, and body temperature (oral). Any changes in vital signs that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant change from baseline in vital signs were reported.'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings', 'timeFrame': 'From the first dose of study treatment up to the end of study (Day 112)', 'description': '12-lead ECG recordings included rhythm, heart rate (as measured by RR interval), PR interval, QRS duration, and QT interval. Any changes in ECG parameters that were deemed clinically significant were judged by the investigator. The number of participants with clinically significant changes from baseline in 12-lead ECG findings were reported.'}, {'measure': 'AUC0-last: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration for Lanadelumab', 'timeFrame': 'Pre-dose (Day 1) up to 2664 hours post-dose', 'description': 'AUC0-last for lanadelumab was reported.'}, {'measure': 'AUC0-inf: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity for Lanadelumab', 'timeFrame': 'Pre-dose (Day 1) up to 2664 hours post-dose', 'description': 'AUC0-inf for lanadelumab was reported.'}, {'measure': 'Cmax1: Maximum Observed Plasma Concentration Following the First IV Dose for Lanadelumab', 'timeFrame': 'Pre-dose (Day 1) up to 2664 hours post-dose', 'description': 'Cmax1 following the first IV dose for lanadelumab was reported.'}, {'measure': 'Cmax2: Maximum Observed Plasma Concentration Following the Second IV Dose for Lanadelumab', 'timeFrame': 'Pre-dose (Day 4) up to 2592 hours post-dose', 'description': 'Cmax2 following the second IV dose for lanadelumab was reported.'}, {'measure': 'Tmax1: Minimum Observed Time to Reach the First Cmax1 for Lanadelumab', 'timeFrame': 'Pre-dose (Day 1) up to 2664 hours post-dose', 'description': 'Tmax1 following the first IV dose for lanadelumab was reported.'}, {'measure': 'Tmax2: Minimum Observed Time to Reach the Second Cmax2 for Lanadelumab', 'timeFrame': 'Pre-dose (Day 4) up to 2592 hours post-dose', 'description': 'Tmax2 following the second IV dose for lanadelumab was reported.'}, {'measure': 'Terminal Half-Life (T1/2) of Lanadelumab in Plasma', 'timeFrame': 'Pre-dose (Day 1) up to 2664 hours post-dose', 'description': 'T1/2 is defined as the time required for the concentration of the drug to reach half of its original value. T1/2 for lanadelumab was reported.'}, {'measure': 'Clearance (CL) of Lanadelumab in Plasma', 'timeFrame': 'Pre-dose (Day 1) up to 2664 hours post-dose', 'description': 'Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body. CL for lanadelumab was reported.'}, {'measure': 'Vss: Volume of Distribution at Steady State in Plasma for Lanadelumab', 'timeFrame': 'Pre-dose (Day 1) up to 2664 hours post-dose', 'description': 'Volume of distribution is 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. Vss for lanadelumab was reported.'}, {'measure': 'First Order Elimination Rate Constant Associated With the Terminal (Log-linear) Portion of the Curve (Lambda z) of Lanadelumab', 'timeFrame': 'Pre-dose (Day 1) up to 2664 hours post-dose', 'description': 'Lambda z of Lanadelumab was reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.takeda.com/study-detail/5f9c5f6a2f8e61001ef3242d', 'label': 'To obtain more information on the study, click here/on this link'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study to evaluate the safety, tolerability and pharmacokinetics (PK) of lanadelumab administered by Intravenous (IV) infusion in healthy adult volunteers.', 'detailedDescription': 'A Randomized, Double-blind, Placebo-Controlled, Repeat-dose, Single-center Phase 1a Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered Intravenously in Healthy Adult Volunteer Subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, adult, male or female, 19-55 years of age, inclusive, at screening.\n* Continuous non-smoker who has not used nicotine-containing products for at least 30 days prior to the first dosing and throughout the study, based on participant self-reporting.\n* Body mass index (BMI) greater than or equal to (\\>=) 18.0 and less than or equal to (\\<=) 32.0 kilogram per square meter (kg/m\\^2) at screening.\n* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), per the investigator.\n* Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.\n* Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol.\n\nExclusion Criteria:\n\n* Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.\n* History or presence of clinically significant medical or psychiatric condition or disease per the investigator.\n* History of any illness that might confound the results of the study or poses an additional risk to the participant by their participation in the study, per the investigator.\n* History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing per the investigator.\n* History or presence of hypersensitivity or idiosyncratic reaction to the study drug(s) or related compounds.\n* History or presence of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gall bladder removal, or current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinically significant clinical or laboratory assessments per the investigator.\n* Female participants with a positive pregnancy test or lactating.\n* Positive urine drug or alcohol results at screening.\n* Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).\n* Supine blood pressure is less than 90/40 millimetre of mercury (mmHg) or greater than 140/90 mmHg at screening.\n* Supine heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at screening.\n* Orthostatic vital sign results with a decrease in systolic greater than (\\>) 20 mmHg or decrease in diastolic \\> 10 mmHg and increase in pulse of \\> 20 beats per minute.\n* QTcF interval is \\> 450 milliseconds (msec) (males) or \\> 470 msec (females) or ECG findings are deemed abnormal with clinical significance at screening per the investigator.\n* Estimated creatinine clearance less than (\\<) 80 milliliters per minute (mL/min) at screening.\n* Unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing and throughout the study. Medication listed as part of acceptable birth control methods will be allowed. Thyroid hormone replacement medication may be permitted if the participant has been on the same stable dose for the immediate 3 months prior to first study drug administration. After randomization/dosing, a nonsteroidal anti-inflammatory drug may be administered at the discretion of the investigator. Hormone replacement therapy will also be allowed if the participant has been on the same stable dose for the immediate 3 months prior to first study drug administration.\n* Has been on a diet incompatible with the on-study diet, per the investigator, within the 30 days prior to the first dosing and throughout the study.\n* Donation of blood or significant blood loss within 56 days prior to the first dosing.\n* Plasma donation within 7 days prior to the first dosing.\n* Participation in another clinical study within 30 days or 5 half-lives prior to the first dosing. The 30-day window or 5 half-lives will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study'}, 'identificationModule': {'nctId': 'NCT04503603', 'briefTitle': 'A Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered Intravenously in Healthy Adult Volunteer Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-Controlled, Repeat-dose, Single-center Phase 1a Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered Intravenously in Healthy Adult Volunteer Subjects', 'orgStudyIdInfo': {'id': 'TAK-743-1003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lanadelumab 300 mg', 'description': 'Participants will receive single dose of lanadelumab 300 mg intravenous (IV) infusion on Day 1 followed by second dose on Day 4.', 'interventionNames': ['Drug: Lanadelumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participant will receive single dose of lanadelumab matching placebo (normal saline) IV infusion on Day 1 followed by second dose on Day 4.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Lanadelumab', 'type': 'DRUG', 'otherNames': ['TAK-743'], 'description': 'Participants will receive lanadelumab 300 mg IV infusion on Day 1 followed by Day 4.', 'armGroupLabels': ['Lanadelumab 300 mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Participants will receive placebo matching to lanadelumab IV infusion on Day 1 followed by Day 4.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Celerion', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda Development Center Americas, Inc.'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/takeda/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': "Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.", 'accessCriteria': 'IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Takeda Development Center Americas, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}