drugset

drugset / Trial / NCT01929226

Safety, Tolerability, and PK of a Single Intravenous Dose of ETI-204 in Adult Volunteers

NCT01929226 ↗

Phase 1 Completed 280 enrolled Elusys Therapeutics

RandomizedParallel-groupDouble-blindOther

Summary

To evaluate the safety and tolerability and pharmacokinetics (PK) of a single intravenous (IV) dose of ETI-204 in adult volunteers.

Timeline

Start: 2013-07-09
Primary completion: 2013-11-29
Completion: 2013-11-29

Publications

Nagy CF, Leach TS, Hoffman JH, Czech A, Carpenter SE, Guttendorf R. Pharmacokinetics and Tolerability of Obiltoxaximab: A Report of 5 Healthy Volunteer Studies. Clin Ther. 2016 Sep;38(9):2083-2097.e7. doi: 10.1016/j.clinthera.2016.07.170. Epub 2016 Aug 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Obiltoxaximab	Monoclonal antibody	16 mg/kg	Intravenous

Indications