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

Sponsor

CSL Behring (Industry)

Overall Status

Completed

CT.gov ID

NCT01542619

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Biological: rVIIa-FP Biological: Placebo (0.9% normal saline)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: rVIIa-FP	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.
Placebo Comparator: Placebo (0.9% normal saline)	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.

Arm

Intervention/Treatment

Experimental: rVIIa-FP

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.

Placebo Comparator: Placebo (0.9% normal saline)

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.

Outcome Measures

Primary Outcome Measures

The frequency of related Adverse Events (AEs) to rVIIa-FP. [28 days]
Number of subjects who develop inhibitors against Factor VII (FVII). [28 days]
Number of subjects who develop antibodies against rVIIa-FP. [28 days]

Secondary Outcome Measures

Area under curve to the last sample with quantifiable drug concentration (AUC0-t) of a single dose of rVIIa-FP [120 hours]
Half- life (t1/2) of a single dose of rVIIa-FP [120 hours]
Incremental recovery (IR) of rVIIa-FP [120 hours]
Clearance (Cl) of a single dose of rVIIa-FP [120 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy male subjects between 18 and 35 years of age, both inclusive.
Body weight between 50.0 and 100.0 kg, both inclusive.
Body mass index (BMI) between 18.0 and 29.9 kg/m2, both inclusive.
Written informed consent for study participation obtained before undergoing any study specific procedures.

Exclusion Criteria:

Subjects at increased cardiovascular risk.
Any clinical sign or known history of atherosclerosis or thromboembolic events.
A subject considered at high risk of thromboembolic events confirmed either from history or by thrombophilia screening test.
Subjects with significant elevation of cholesterol level.
Renal dysfunction.
Overt bleeding.
Smokers with positive cotinine test at screening.
Participation in any other trial investigating a procoagulant within the last six months prior to screening.
Known or suspected hypersensitivity to the investigational medicinal product (IMP), or to any excipients of the IMP.
Contraindications to Warfarin (Coumadin®).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phase I Unit	Berlin		Germany

Sponsors and Collaborators

CSL Behring

Investigators

Study Director: Alex Veldman, M.D., CSL Behring

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CSL Behring

ClinicalTrials.gov Identifier:

NCT01542619

Other Study ID Numbers:

CSL689_1001
2011-004568-32

First Posted:

Mar 2, 2012

Last Update Posted:

Apr 21, 2017

Last Verified:

Mar 1, 2013

Study Results

No Results Posted as of Apr 21, 2017