Trials / Completed
CompletedNCT00960362
An Investigation of AGS-009 in Patients With Systemic Lupus Erythematosus (SLE)
A Randomised, Double-blind, Placebo-controlled, and Single Dose-escalation Trial of AGS-009 Administered in Subjects With Systemic Lupus Erythematosus
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Argos Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This trial is conducted in North America. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic and signs of bioactivity of increasing single doses of AGS-009 in patients with systemic lupus erythematosus (SLE).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AGS-009 | Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein) |
| DRUG | placebo | Single dose of 0 mg/kg administered intravenously (in the vein) cohort 1-6. |
Timeline
- Start date
- 2009-07-01
- Primary completion
- 2011-12-01
- Completion
- 2011-12-01
- First posted
- 2009-08-17
- Last updated
- 2012-01-30
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00960362. Inclusion in this directory is not an endorsement.