Trials / Terminated
TerminatedNCT01374503
First in Man Study of ALX-0651, a Nanobody Inhibiting CXCR4
A Phase I, Single-centre, Randomised, Single-blinded, Placebo-controlled Single Ascending Dose Study, Followed by an Open-label Extension, Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of ALX-0651, Administered Intravenously to Healthy Male Volunteers
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Ablynx, a Sanofi company · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this first-in-man Phase I study is to determine whether the CXCR4-inhibitor ALX-0651 is safe and effective after single or multiple intravenous administrations to healthy male volunteers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ALX-0651 | single or multiple (once daily for maximum 3 consecutive days) i.v. administration, 0.003-12 mg/kg |
| BIOLOGICAL | Placebo | single or multiple i.v. administration |
Timeline
- Start date
- 2011-06-01
- Primary completion
- 2012-01-01
- Completion
- 2012-01-01
- First posted
- 2011-06-16
- Last updated
- 2012-04-17
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT01374503. Inclusion in this directory is not an endorsement.