A Safety and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor VIIa With Albumin (rVIIa-FP) in Healthy Male Volunteers

Phase 1 Completed 40 enrolled CSL Behring

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a first in man, prospective, single-center, randomized, double-blind, dose-escalation cohort study to investigate tolerability, safety and pharmacokinetics of rVIIa-FP in comparison to placebo.

Timeline

Start: 2012-03
Primary completion: 2012-06
Completion: 2012-07

Publications

Results Golor G, Bensen-Kennedy D, Haffner S, Easton R, Jung K, Moises T, Lawo JP, Joch C, Veldman A. Safety and pharmacokinetics of a recombinant fusion protein linking coagulation factor VIIa with albumin in healthy volunteers. J Thromb Haemost. 2013 Nov;11(11):1977-85. doi: 10.1111/jth.12409.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	rVIIa-FP	Protein / enzyme biologic	140 ug/kg	Intravenous
Subject	rVIIa-FP	Protein / enzyme biologic	300 ug/kg	Intravenous
Subject	rVIIa-FP	Protein / enzyme biologic	500 ug/kg	Intravenous
Subject	rVIIa-FP	Protein / enzyme biologic	750 ug/kg	Intravenous
Subject	rVIIa-FP	Protein / enzyme biologic	1000 ug/kg	Intravenous

Indications

No indication recorded.