CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
MEDI6012 +2 morebiological
Likely dose
MEDI6012 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02601560
NCT02601560Phase 2Completed
CompareCT.gov

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

MedImmune LLC·interventional·Posted Nov 10, 2015·Updated Mar 19, 2018

In Brief

A Phase 2 clinical trial evaluating MEDI6012, Placebo SC, and 1 other intervention for Coronary Artery Disease. Completed, enrolled 48 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 10, 2015
Enrollment StartDec 3, 2015
Primary CompletionAug 20, 2016
Study CompletionNov 3, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.6 years ago

Interventions

MEDI6012biological

Participants received a single IV (24, 80, 240, and 800 mg) and SC (80 and 600 mg) MEDI6012 doses on Day 1.

Placebo SCbiological

Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.

Placebo IVbiological

Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.