Safety, Tolerability and Pharmacokinetics of SAR231893 (REGN668) in Healthy Japanese Adult Male Subjects

Phase 1 Completed 32 enrolled Sanofi Regeneron Pharmaceuticals · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

Primary Objective: Assess the safety and tolerability of SAR231893 (REGN668) after ascending single subcutaneous (SC) doses in healthy Japanese adult male subjects Secondary Objectives: Assess the following parameters after ascending single SC doses in healthy Japanese adult male subjects * The pharmacokinetics of SAR231893 (REGN668) * The immunogenicity of SAR231893 (REGN668) * Exploratory analyses of the pharmacodynamics of SAR231893 (REGN668)

Timeline

Start: 2012-03
Primary completion: 2012-10
Completion: 2012-10

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.