Trials / Completed
CompletedNCT02601560
To Evaluate Safety, Pharmacokinetics and Pharmacodynamics of MEDI6012 in Subjects With Stable Coronary Artery Disease
A Phase 2a Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single- Ascending Doses of MEDI6012 in Subjects With Stable Coronary Artery Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- MedImmune LLC · Industry
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 2a randomized, double-blind (subject/investigator blinded, MedImmune unblinded), placebo-controlled, dose-escalation study to evaluate the safety, PK/PD, and immunogenicity of single IV and SC MEDI6012 doses in adult subjects with stable CAD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MEDI6012 | Participants received a single IV (24, 80, 240, and 800 mg) and SC (80 and 600 mg) MEDI6012 doses on Day 1. |
| BIOLOGICAL | Placebo SC | Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study. |
| BIOLOGICAL | Placebo IV | Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study. |
Timeline
- Start date
- 2015-12-03
- Primary completion
- 2016-08-20
- Completion
- 2016-11-03
- First posted
- 2015-11-10
- Last updated
- 2018-03-19
- Results posted
- 2018-03-19
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02601560. Inclusion in this directory is not an endorsement.