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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT01542619
First received: February 26, 2012
Last updated: March 7, 2013
Last verified: March 2013
  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 April 17, 2014