Trials / Completed
CompletedNCT02101073
ALX-0061 Phase I Bioavailability Study in Healthy Volunteers
A Phase I, Open-Label Study Evaluating the Bioavailability of ALX-0061 After Subcutaneous and Intravenous Administration in Healthy Volunteers.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Ablynx, a Sanofi company · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The overall aims of the study are: * To assess the bioavailability of single doses of ALX-0061, administered s.c. at three dose levels, using 2 corresponding single i.v. dose levels as reference. * To provide additional information on pharmacokinetics and pharmacodynamics of ALX-0061. * To further determine the safety and tolerability of ALX-0061. * To further evaluate the systemic (serum) immunogenicity of ALX-0061.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ALX-0061 | single dose, intravenous |
| BIOLOGICAL | ALX-0061 | single dose, subcutaneous |
Timeline
- Start date
- 2014-03-31
- Primary completion
- 2014-07-31
- Completion
- 2014-07-31
- First posted
- 2014-04-01
- Last updated
- 2019-01-04
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT02101073. Inclusion in this directory is not an endorsement.