A First-In-Human Study With a Single Dose UCB7665 in Healthy Volunteers

NCT02220153 ↗

Phase 1 Completed 41 enrolled UCB Celltech Parexel · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

This study is designed to evaluate the safety and tolerability of single ascending doses of UCB7665 administered by intravenous or subcutaneous infusion in healthy subjects.

Timeline

Start: 2014-07
Primary completion: 2015-09
Completion: 2015-09

Publications

Kiessling P, Lledo-Garcia R, Watanabe S, Langdon G, Tran D, Bari M, Christodoulou L, Jones E, Price G, Smith B, Brennan F, White I, Jolles S. The FcRn inhibitor rozanolixizumab reduces human serum IgG concentration: A randomized phase 1 study. Sci Transl Med. 2017 Nov 1;9(414):eaan1208. doi: 10.1126/scitranslmed.aan1208.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rozanolixizumab	Monoclonal antibody	1 mg/kg	Intravenous
Subject	Rozanolixizumab	Monoclonal antibody	4 mg/kg	Intravenous
Subject	Rozanolixizumab	Monoclonal antibody	7 mg/kg	Intravenous

Indications

No indication recorded.