NCT01844804CompletedPhase 1
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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 146
- Locations
- 2
- Primary Endpoint
- Maximum Observed Serum Concentration (Cmax)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Maximum Observed Serum Concentration (Cmax)
Time Frame: Day 1 - Day 57
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUCt)
Time Frame: Day 1 - Day 57
Area Under the Curve From Time Zero Extrapolated to Infinite Time (AUCinf)
Time Frame: Day 1 - Day 57
Secondary Outcomes
- Volume of Distribution at Steady State (Vss)(Day 1 - Day 57)
- Systemic Clearance (CL)(Day 1 - Day 57)
- Terminal Disposition Half-Life (t1/2)(Day 1 - Day 57)
- Incidence of anti-infliximab antibodies (ADA), including neutralizing antibodies (Nab)(Day 1 - LSLV or Day 85 whichever occurs later)
Investigators
Study Sites (2)
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