A Trial in Healthy Chinese Volunteers to Test How Different Doses of BI 655130 Are Taken up in the Body

Phase 1 Completed 50 enrolled Boehringer Ingelheim

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this trial is to investigate pharmacokinetics, including dose proportionality, following single intravenous and subcutaneous doses of spesolimab in healthy Chinese subjects.

Timeline

Start: 2020-05-21
Primary completion: 2021-04-07
Completion: 2021-06-04

Publications

Cao G, Yang H, Wang J, Ishida M, Thoma C, Haeufel T, Bossert S, Zhang J. Pharmacokinetics and Safety of Spesolimab in Healthy Chinese Subjects: An Open-Label, Phase I Study. Adv Ther. 2024 Sep;41(9):3557-3568. doi: 10.1007/s12325-024-02940-8. Epub 2024 Jul 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Spesolimab	Monoclonal antibody	300 mg	Intravenous
Subject	Spesolimab	Monoclonal antibody	450 mg	Intravenous
Subject	Spesolimab	Monoclonal antibody	600 mg	Intravenous
Subject	Spesolimab	Monoclonal antibody	900 mg	Intravenous
Subject	Spesolimab	Monoclonal antibody	1200 mg	Intravenous

Indications

No indication recorded.