Comparison of the Pharmacokinetics and Safety of Two SAR231893 (REGN668) Drug Products in Healthy Subjects

Phase 1 Completed 30 enrolled Sanofi Regeneron Pharmaceuticals · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

Primary Objective: To determine and compare the pharmacokinetic (PK) profiles of 2 different SAR231893 (REGN668) drug products after administration of a single subcutaneous (SC) dose Secondary Objective: To determine and compare the safety and tolerability of the 2 SAR231893 (REGN668) drug products after administration of a single SC dose

Timeline

Start: 2012-02
Primary completion: 2012-07
Completion: 2012-07

Publications

Li Z, Radin A, Li M, Hamilton JD, Kajiwara M, Davis JD, Takahashi Y, Hasegawa S, Ming JE, DiCioccio AT, Li Y, Kovalenko P, Lu Q, Ortemann-Renon C, Ardeleanu M, Swanson BN. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Dupilumab in Healthy Adult Subjects. Clin Pharmacol Drug Dev. 2020 Aug;9(6):742-755. doi: 10.1002/cpdd.798. Epub 2020 Apr 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dupilumab	Monoclonal antibody	—	Subcutaneous

Indications

No indication recorded.