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

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.

Timeline

Start

2013-05

Primary completion

2013-11

Completion

2013-11

Outcome

Met primary endpoint

paper The 90% CIs for test-to-reference ratios for Cmax, AUCT, and AUCinf were within 80.00-125.00% PMID 29504427 ↗

paper This study demonstrated PK similarity of PF-06438179/GP1111 to infliximab-EU and infliximab-US PMID 29504427 ↗

Publications

• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Infliximab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	PF-06438179	Unknown	10 mg/kg	Intravenous

Indications

No indication recorded.