Clinical trial NCT01844804: A Pharmacokinetics Study Comparing PF-06438179 and Infliximab in Healthy Volunteers (REFLECTIONS B537-01)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Biosimilarity
Similarity
PK
Phase 1
Infliximab
Healthy Volunteers
Single-dose
Immunology
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-05-01
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
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
Secondary outcomes:
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
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.