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

Purpose

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	Intervention	Phase
Healthy	Biological: rVIIa-FP Biological: Placebo (0.9% normal saline)	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by CSL Behring:

Primary Outcome Measures:

The frequency of related Adverse Events (AEs) to rVIIa-FP. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Number of subjects who develop inhibitors against Factor VII (FVII). [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Number of subjects who develop antibodies against rVIIa-FP. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Area under curve to the last sample with quantifiable drug concentration (AUC0-t) of a single dose of rVIIa-FP [ Time Frame: 120 hours ] [ Designated as safety issue: No ]
Half- life (t1/2) of a single dose of rVIIa-FP [ Time Frame: 120 hours ] [ Designated as safety issue: No ]
Incremental recovery (IR) of rVIIa-FP [ Time Frame: 120 hours ] [ Designated as safety issue: No ]
Clearance (Cl) of a single dose of rVIIa-FP [ Time Frame: 120 hours ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	March 2012
Study Completion Date:	July 2012

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542619

Locations

Germany
Phase I Unit
Berlin, Germany

Sponsors and Collaborators

CSL Behring

Investigators

Study Director:

Alex Veldman, M.D.

CSL Behring

More Information

No publications provided

Responsible Party:	CSL Behring
ClinicalTrials.gov Identifier:	NCT01542619 History of Changes
Other Study ID Numbers:	CSL689_1001, 2011-004568-32
Study First Received:	February 26, 2012
Last Updated:	March 7, 2013
Health Authority:	Germany: Paul-Ehrlich-Institut

ClinicalTrials.gov processed this record on June 17, 2013