A Pharmacokinetics Study Comparing PF-06438179 and Infliximab in Healthy Volunteers (REFLECTIONS B537-01)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Biological: PF-06438179
* Biological: Remicade
* Biological: Remicade


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Body Mass Index (BMI) of 17.5 to 32.0 kg/m2; and a total body weight >50kg (110 lbs). Exclusion Criteria: 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). Previous exposure to a monoclonal antibody, or current use of other biologics. History of hypersensitivity reaction to inactive components of the study drugs or any murine proteins or anaphylactic reactions to therapeutic drugs. History of tuberculosis (TB) or a positive latent TB test at Screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A = PF-06438179<br> | Biological: PF-06438179<br>* Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1<br>* Other names: Infliximab-Pfizer;|
| Active Comparator: B = Infliximab-EU<br> | Biological: Remicade<br>* Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1<br>* Other names: Infliximab (European Union);|
| Active Comparator: C = Infliximab-US<br> | Biological: Remicade<br>* Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1<br>* Other names: Infliximab (United States);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Serum Concentration (Cmax) |  | Day 1 - Day 57 | 
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt) |  | Day 1 - Day 57 | 
| Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf) |  | Day 1 - Day 57 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic Clearance (CL) |  | Day 1 - Day 57 | 
| Terminal Disposition Half-Life (t1/2) |  | Day 1 - Day 57 | 
| Volume of Distribution at Steady State (Vss) |  | Day 1 - Day 57 | 
| Incidence of anti-infliximab antibodies (ADA), including neutralizing antibodies (Nab) |  | Day 1 - LSLV or Day 85 whichever occurs later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunology, Bioequivalence, Biosimilarity, Similarity, PK, Phase 1, Infliximab, Healthy Volunteers, Single-dose