Single Rising Dose Trial of Spesolimab (BI 655130) for Healthy Japanese Male Subjects

Summary

The primary objective of this trial is to investigate the safety and tolerability of spesolimab following administration of single rising intravenous doses and single subcutaneous dose in healthy Japanese male volunteers. Secondary objective is the exploration of the pharmacokinetics including dose proportionality of spesolimab in healthy Japanese male volunteers.

Timeline

Start

2017-05-16

Primary completion

2018-01-04

Completion

2018-01-04

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

Indications

No indication recorded.