A Study of Single Dose Inclacumab in Japanese Healthy Volunteers Compared to Caucasian Healthy Volunteers

Phase 1 Completed 62 enrolled Hoffmann-La Roche

RandomizedParallel-groupOpen-label

Summary

This open-label, parallel group study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of inclacumab in Japanese healthy volunteers compared to Caucasian healthy volunteers. Subjects will receive a single intravenous dose of inclacumab. Follow-up will be for up to 197 days.

Timeline

Start: 2013-06
Primary completion: 2014-02
Completion: 2014-02

Publications

Morrison M, Palermo G, Schmitt C. Lack of ethnic differences in the pharmacokinetics and pharmacodynamics of inclacumab in healthy Japanese and Caucasian subjects. Eur J Clin Pharmacol. 2015 Nov;71(11):1365-74. doi: 10.1007/s00228-015-1938-4. Epub 2015 Sep 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Inclacumab	Monoclonal antibody	0.3 mg/kg	Intravenous
Subject	Inclacumab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	Inclacumab	Monoclonal antibody	20 mg/kg	Intravenous

Indications

No indication recorded.