A Study in Healthy People to Measure the Amount of BI 655130 in the Blood After Injecting Different Doses Into Different Parts of the Body

Phase 1 Completed 48 enrolled Boehringer Ingelheim

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this trial is to investigate the relative bioavailability of BI 655130 administered as two subcutaneous injections in the left and right periumbilical region compared to a single subcutaneous periumbilical injection of BI 655130. The secondary objective is to investigate the relative bioavailability of a single subcutaneous injection of BI 655130 into the thigh compared to a single subcutaneous periumbilical injection of BI 655130.

Timeline

Start: 2018-08-16
Primary completion: 2019-06-03
Completion: 2019-06-03

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.