Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-02-27 @ 2:21 PM
Study NCT ID:
NCT01844804
Status:
COMPLETED
Last Update Posted:
2014-01-07
First Post:
2013-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pharmacokinetics Study Comparing PF-06438179 and Infliximab in Healthy Volunteers (REFLECTIONS B537-01)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000630865', 'term': 'GP1111'}, {'id': 'D000069285', 'term': 'Infliximab'}], 'ancestors': [{'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-06', 'studyFirstSubmitDate': '2013-04-29', 'studyFirstSubmitQcDate': '2013-04-29', 'lastUpdatePostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Serum Concentration (Cmax)', 'timeFrame': 'Day 1 - Day 57'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt)', 'timeFrame': 'Day 1 - Day 57'}, {'measure': 'Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf)', 'timeFrame': 'Day 1 - Day 57'}], 'secondaryOutcomes': [{'measure': 'Systemic Clearance (CL)', 'timeFrame': 'Day 1 - Day 57'}, {'measure': 'Terminal Disposition Half-Life (t1/2)', 'timeFrame': 'Day 1 - Day 57'}, {'measure': 'Volume of Distribution at Steady State (Vss)', 'timeFrame': 'Day 1 - Day 57'}, {'measure': 'Incidence of anti-infliximab antibodies (ADA), including neutralizing antibodies (Nab)', 'timeFrame': 'Day 1 - LSLV or Day 85 whichever occurs later'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioequivalence', 'Biosimilarity', 'Similarity', 'PK', 'Phase 1', 'Infliximab', 'Healthy Volunteers', 'Single-dose', 'Immunology'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '29504427', 'type': 'DERIVED', 'citation': 'Palaparthy R, Udata C, Hua SY, Yin D, Cai CH, Salts S, Rehman MI, McClellan J, Meng X. A randomized study comparing the pharmacokinetics of the potential biosimilar PF-06438179/GP1111 with Remicade(R) (infliximab) in healthy subjects (REFLECTIONS B537-01). Expert Rev Clin Immunol. 2018 Apr;14(4):329-336. doi: 10.1080/1744666X.2018.1446829. Epub 2018 Mar 12.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5371001&StudyName=A%20Pharmacokinetics%20Study%20Comparing%20PF-06438179%20and%20Infliximab%20in%20Healthy%20Volunteers%20%28REFLECTIONS%20B537-01%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'In this study, healthy volunteers will receive a single intravenous dose of either PF-06438179 or infliximab (United States) or infliximab (European Union). During the course of the study, the pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms of PF-06438179 and the licensed infliximab products. Safety, tolerability, and immunologic response will also be evaluated throughout.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy female subjects of non-childbearing potential and healthy male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).\n* Body Mass Index (BMI) of 17.5 to 32.0 kg/m2; and a total body weight \\>50kg (110 lbs).\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant infectious, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, autoimmune, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).\n* Previous exposure to a monoclonal antibody, or current use of other biologics.\n* History of hypersensitivity reaction to inactive components of the study drugs or any murine proteins or anaphylactic reactions to therapeutic drugs.\n* History of tuberculosis (TB) or a positive latent TB test at Screening.'}, 'identificationModule': {'nctId': 'NCT01844804', 'briefTitle': 'A Pharmacokinetics Study Comparing PF-06438179 and Infliximab in Healthy Volunteers (REFLECTIONS B537-01)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study of PF-06438179 and Infliximab Sourced From US and EU Administered to Healthy Volunteers', 'orgStudyIdInfo': {'id': 'B5371001'}, 'secondaryIdInfos': [{'id': 'REFLECTIONS B537-01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A = PF-06438179', 'interventionNames': ['Biological: PF-06438179']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B = Infliximab-EU', 'interventionNames': ['Biological: Remicade']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C = Infliximab-US', 'interventionNames': ['Biological: Remicade']}], 'interventions': [{'name': 'PF-06438179', 'type': 'BIOLOGICAL', 'otherNames': ['Infliximab-Pfizer'], 'description': 'Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1', 'armGroupLabels': ['A = PF-06438179']}, {'name': 'Remicade', 'type': 'BIOLOGICAL', 'otherNames': ['Infliximab (European Union)'], 'description': 'Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1', 'armGroupLabels': ['B = Infliximab-EU']}, {'name': 'Remicade', 'type': 'BIOLOGICAL', 'otherNames': ['Infliximab (United States)'], 'description': 'Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1', 'armGroupLabels': ['C = Infliximab-US']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}