Trials / Completed
CompletedNCT00946699
A Study of the Safety and Tolerability of MEDI-551 in Scleroderma
A Phase 1, Randomized, Double-blind, Placebo-controlled Study of the Safety and Tolerability of MEDI-551 in Scleroderma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- MedImmune LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the safety and tolerability of intravenously administered MEDI-551 over escalating single doses in adult subjects with Scleroderma
Detailed description
To evaluate the safety and tolerability of escalating single IV doses of MEDI-551 in adult subjects with scleroderma who have at least moderate skin thickening in an area suitable for repeat biopsy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MEDI-551 | 0.1 mg/kg |
| BIOLOGICAL | Placebo | 0.3 mg/kg |
| BIOLOGICAL | MEDI-551 | 1.0 mg/kg |
| BIOLOGICAL | MEDI-551 | 3.0 mg/kg |
| BIOLOGICAL | MEDI-551 | 10.0 mg/kg |
| OTHER | Placebo | Placebo |
Timeline
- Start date
- 2010-03-01
- Primary completion
- 2012-03-01
- Completion
- 2014-03-01
- First posted
- 2009-07-27
- Last updated
- 2014-11-13
Locations
14 sites across 3 countries: United States, Canada, United Kingdom
Source: ClinicalTrials.gov record NCT00946699. Inclusion in this directory is not an endorsement.