Trials / Completed
CompletedNCT02418793
A Study of a Long-Acting r-Factor 7a (Factor VIIa) in Adult Men With Hemophilia A or B
A Phase 1/2a, Open-Label, Multicenter, Dose Escalation Study to Assess the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) Profile of a Long Acting Recombinant FVIIa (MOD-5014) in Adult Men With Hemophilia A or B
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- OPKO Health, Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the current Phase 1/2a single dose, dose-escalating study is to evaluate the acute safety, pharmacokinetics (PK) and pharmacodynamics (PD) properties of MOD-5014 in adult subjects with moderate/severe congenital hemophilia A or B. This will be a single-dose, open label, dose-escalating study. Each dose cohort will be concluded by a safety review, following which escalation to the next dose cohort will be approved.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MOD-5014 | Long Acting Factor VIIa |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2018-09-01
- Completion
- 2018-09-01
- First posted
- 2015-04-16
- Last updated
- 2021-05-20
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02418793. Inclusion in this directory is not an endorsement.