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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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rVIIa-FP

Group Type EXPERIMENTAL

rVIIa-FP

Intervention Type BIOLOGICAL

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 (0.9% normal saline)

Group Type PLACEBO_COMPARATOR

Placebo (0.9% normal saline)

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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®).

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes