Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655130 in Healthy Male Volunteers

Phase 1 Completed 78 enrolled Boehringer Ingelheim

RandomizedParallel-groupSingle-blindTreatment

Summary

The aim of this study is to investigate the safety and tolerability of BI 655130 in healthy male subjects following single rising low, medium and high doses.

Timeline

Start: 2015-09-14
Primary completion: 2016-05-27
Completion: 2016-05-27

Publications

Joseph D, Thoma C, Haeufel T, Li X. Assessment of the Pharmacokinetics and Safety of Spesolimab, a Humanised Anti-interleukin-36 Receptor Monoclonal Antibody, in Healthy Non-Japanese and Japanese Subjects: Results from Phase I Clinical Studies. Clin Pharmacokinet. 2022 Dec;61(12):1771-1787. doi: 10.1007/s40262-022-01176-5. Epub 2022 Dec 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Spesolimab	Monoclonal antibody	—	Intravenous

Indications

No indication recorded.