Trials / Completed
CompletedNCT00612196
A Phase I Study of Monoclonal Antibody TB-402 in Healthy Male Volunteers
A Randomised, Phase I, Single Dose, Placebo-Controlled, Dose Escalation Study of TB-402, A Monocloncal Antibody Directed Against FACTOR VIII, Administered Intravenously in Healthy Male Volunteers.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- ThromboGenics · Industry
- Sex
- Male
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
Dose escalation study to assess the safety and tolerability of TB-402, a monoclonal antibody directed against FVIII, versus placebo in healthy male volunteers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TB-402 | Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes |
| DRUG | Placebo |
Timeline
- Start date
- 2007-03-01
- Primary completion
- 2007-10-01
- Completion
- 2007-12-01
- First posted
- 2008-02-11
- Last updated
- 2014-04-07
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT00612196. Inclusion in this directory is not an endorsement.