NL-OMON34613
Completed
Not Applicable
A Phase I, Dose Escalation Study on the Safety, Pharmacokinetics and Pharmacodynamics of Coagulation Factor VIIa (Recombinant) and its Comparability to NovoSeven® in Healthy Male Volunteers Pre-Treated with Fondaparinux - Recombinant human factor VIIa FIH
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- haemophilia
- Sponsor
- Centre for Human Drug Research
- Enrollment
- 36
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male volunteers, 19\-45 years of age, BMI 19\-30 kg/m^2
Exclusion Criteria
- •Bleeding or coagulation disorder, recent trauma, thromboembolic event, history of administration of any rhFVIIa product, positive reaction to rabbit allergens. See protocol for detailed list of exclusion criteria.
Outcomes
Primary Outcomes
Not specified
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