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Completed

NCT Number: NCT01542619

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

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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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Phase I Unit

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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®).

Treatment and study plan

rVIIa-FP

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)

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.

Primary outcomes

  1. The frequency of related Adverse Events (AEs) to rVIIa-FP.

    Time frame: 28 days

  2. Number of subjects who develop inhibitors against Factor VII (FVII).

    Time frame: 28 days

  3. Number of subjects who develop antibodies against rVIIa-FP.

    Time frame: 28 days

Secondary outcomes

  1. Area under curve to the last sample with quantifiable drug concentration (AUC0-t) of a single dose of rVIIa-FP

    Time frame: 120 hours

  2. Half- life (t1/2) of a single dose of rVIIa-FP

    Time frame: 120 hours

  3. Incremental recovery (IR) of rVIIa-FP

    Time frame: 120 hours

  4. Clearance (Cl) of a single dose of rVIIa-FP

    Time frame: 120 hours

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 2, 2012
Registry last updated
Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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