NCT01542619

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

A Randomized, Placebo-controlled, Single Center, 5 Cohort Dose Escalation Trial to Investigate Safety and Pharmacokinetics of rVIIa-FP (CSL689) in Comparison to Placebo in Healthy Male Human Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: CSL Behring · Industry
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	rVIIa-FP	Recombinant VIIa-FP (rVIIa-FP) is a fusion protein linking coagulation factor VIIa with albumin and will be administered by intravenous infusion in escalating doses up to 1000 mcg/kg. Participants will receive pre-treatment with an oral anticoagulant starting 7 days prior to administration of study product and continuing for 7 days after study product has been administered.
BIOLOGICAL	Placebo (0.9% normal saline)	Placebo will be administered by intravenous infusion. Participants will receive pre-treatment with an oral anticoagulant starting 7 days prior to administration of placebo and continuing for 7 days after placebo has been administered.

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-06-01
• Completion: 2012-07-01
• First posted: 2012-03-02
• Last updated: 2017-04-21

Locations

1 site across 1 country: Germany