A Study of Intravenously or Subcutaneously Administered REGN3500 in Healthy Adult Subjects

Phase 1 Completed 40 enrolled Regeneron Pharmaceuticals Sanofi · collab

RandomizedParallel-groupTriple-blindOther

Summary

The primary objective of this study is to evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses of REGN3500 in healthy adult males and females

Timeline

Start: 2016-08
Primary completion: 2017-06-18
Completion: 2017-10-03

Publications

Kosloski MP, Kalliolias GD, Xu CR, Harel S, Lai CH, Zheng W, Davis JD, Kamal MA. Pharmacokinetics and pharmacodynamics of itepekimab in healthy adults and patients with asthma: Phase I first-in-human and first-in-patient trials. Clin Transl Sci. 2022 Feb;15(2):384-395. doi: 10.1111/cts.13157. Epub 2021 Sep 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Itepekimab	Monoclonal antibody	0.3 mg/kg	Intravenous
Subject	Itepekimab	Monoclonal antibody	1 mg/kg	Intravenous
Subject	Itepekimab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	Itepekimab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Itepekimab	Monoclonal antibody	150 mg	Intravenous

Indications

No indication recorded.