Trials / Completed
CompletedNCT02524782
A Phase 1, Single- and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MEDI4166 in Subjects With Type 2 Diabetes
A Phase 1, Combined Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of MEDI4166 in Subjects With Type 2 Diabetes Mellitus (T2D)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 103 (actual)
- Sponsor
- MedImmune LLC · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
A Phase 1, combined Single Ascending Dose (SAD) and Multiple-ascending Dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MEDI4166 in Subjects with Type 2 Diabetes Mellitus (T2D).
Detailed description
This study is a first time in human (FTIH), Phase 1, randomized, double-blind study to evaluate the safety, tolerability, PK, and PD of MEDI4166 administered as both single and multiple ascending doses to subjects with T2D.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MEDI-4166 | MEDI-4166 administered subcutaneously |
| BIOLOGICAL | Placebo | Placebo administered subcutaneously |
Timeline
- Start date
- 2015-10-07
- Primary completion
- 2017-04-14
- Completion
- 2017-04-14
- First posted
- 2015-08-17
- Last updated
- 2019-03-13
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02524782. Inclusion in this directory is not an endorsement.