Trials / Terminated
TerminatedNCT01189422
Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes
A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Subcutaneously Administered Teplizumab (MGA031) in Adults With Type 1 Diabetes Mellitus
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- MacroGenics · Industry
- Sex
- All
- Age
- 18 Years – 35 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of subcutaneously administered teplizumab in adults with relatively recent onset T1DM, greater than 12 weeks and less than 52 weeks of presentation of first signs and symptoms of disease to a physician prior to randomization.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | teplizumab or placebo | infusion or injection |
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2011-02-01
- Completion
- 2011-02-01
- First posted
- 2010-08-26
- Last updated
- 2022-02-08
Source: ClinicalTrials.gov record NCT01189422. Inclusion in this directory is not an endorsement.