Single Rising Dose Study (Intravenous Infusion and Subcutaneous Injection) of BI 655064 in Healthy Male Volunteers

Phase 1 Completed 72 enrolled Boehringer Ingelheim

RandomizedSingle-groupSingle-blindTreatment

Summary

To investigate safety and tolerability of BI 655064 in healthy male volunteers following intravenous infusion of escalating single doses and following subcutaneous injection. Exploration of the pharmacokinetics and pharmacodynamics of BI 655064 after single dosing and determination of the bioavailability of subcutaneous injections of BI 655064.

Timeline

Start: 2012-01
Primary completion: 2012-09
Completion: 2012-09

Publications

Albach FN, Wagner F, Huser A, Igel J, Joseph D, Hilbert J, Schoelch C, Padula SJ, Steffgen J. Safety, pharmacokinetics and pharmacodynamics of single rising doses of BI 655064, an antagonistic anti-CD40 antibody in healthy subjects: a potential novel treatment for autoimmune diseases. Eur J Clin Pharmacol. 2018 Feb;74(2):161-169. doi: 10.1007/s00228-017-2362-8. Epub 2017 Nov 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BI 655064	Monoclonal antibody	0.2 mg	Intravenous
Subject	BI 655064	Monoclonal antibody	40 mg	Subcutaneous
Subject	BI 655064	Monoclonal antibody	120 mg	Intravenous
Subject	BI 655064	Monoclonal antibody	120 mg	Subcutaneous

Indications

No indication recorded.