A Phase I Study of Monoclonal Antibody TB-402 in Healthy Male Volunteers

Phase 1 Completed 56 enrolled ThromboGenics BioInvent International AB · collab

RandomizedParallel-groupDouble-blind

Summary

Dose escalation study to assess the safety and tolerability of TB-402, a monoclonal antibody directed against FVIII, versus placebo in healthy male volunteers.

Timeline

Start: 2007-03
Primary completion: 2007-10
Completion: 2007-12

Publications

Verhamme P, Pakola S, Jensen TJ, Berggren K, Sonesson E, Saint-Remy JM, Balchen T, Belmans A, Cahillane G, Stassen JM, Peerlinck K, Glazer S, Jacquemin M. Tolerability and pharmacokinetics of TB-402 in healthy male volunteers. Clin Ther. 2010 Jun;32(6):1205-20. doi: 10.1016/j.clinthera.2010.06.012.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TB-402	Monoclonal antibody	0.015 ug/kg	Intravenous
Subject	TB-402	Monoclonal antibody	0.1 ug/kg	Intravenous
Subject	TB-402	Monoclonal antibody	0.5 ug/kg	Intravenous
Subject	TB-402	Monoclonal antibody	2.5 ug/kg	Intravenous
Subject	TB-402	Monoclonal antibody	12.5 ug/kg	Intravenous
Subject	TB-402	Monoclonal antibody	37.5 ug/kg	Intravenous
Subject	TB-402	Monoclonal antibody	188 ug/kg	Intravenous
Subject	TB-402	Monoclonal antibody	620 ug/kg	Intravenous
Subject	TB-402	Monoclonal antibody	1860 ug/kg	Intravenous

Indications

No indication recorded.