Trials / Completed
CompletedNCT01459562
First in Human Study of an Anti-IFN Gamma Monoclonal Antibody in Healthy Volunteers
A Randomized Double-blinded Placebo Controlled Single Center Phase I Study of Escalating Single Intravenous Doses of NI-0501 in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Swedish Orphan Biovitrum · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic profiles of a novel therapeutic drug when administered to healthy volunteers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NI-0501 | |
| DRUG | Placebo |
Timeline
- Start date
- 2011-09-01
- Primary completion
- 2013-01-01
- Completion
- 2013-01-01
- First posted
- 2011-10-25
- Last updated
- 2023-08-09
Locations
2 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01459562. Inclusion in this directory is not an endorsement.