Safety, Tolerability, and Pharmacokinetics of a Subcutaneous and Intravenous Dose of BI 655130 in Healthy Subjects

Phase 1 Completed 36 enrolled Boehringer Ingelheim

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this trial is to investigate the relative bioavailability of BI 655130 following subcutaneous administration (Test, T) compared to BI 655130 following intravenous infusion (Reference, R). The secondary objective is the evaluation and comparison of several pharmacokinetic parameters between all tested treatments.

Timeline

Start: 2017-04-24
Primary completion: 2018-01-10
Completion: 2018-01-10

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	—	Subcutaneous

Indications

No indication recorded.