To Evaluate Safety, Pharmacokinetics and Pharmacodynamics of MEDI6012 in Subjects With Stable Coronary Artery Disease

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-03

Study Completion Date

2016-11-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Multiple Ascending Doses of MEDI6012 in Subjects With Stable Atherosclerotic Cardiovascular Disease

NCT03004638

Atherosclerosis Cardiovascular Disease

COMPLETED PHASE2

Study to Evaluate the Effects of MEDI6012 on Apolipoprotein B100 Metabolism

NCT03773172

Cardiovascular Diseases

TERMINATED PHASE2

A Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of RBD4059 in Participants With Stable Coronary Artery Disease

NCT06717074

Stable Coronary Artery Disease CAD

ACTIVE_NOT_RECRUITING PHASE2

Efficacy and Safety of MEDI6570 in Patients With a History of Myocardial Infarction

NCT04610892

Coronary Heart Disease (CHD)

COMPLETED PHASE2

GS-6615 in Adults With Chronic Stable Angina and Coronary Artery Disease

NCT02377336

Ischemic Heart Disease

WITHDRAWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MEDI6012 24 mg IV

Participants received a single IV dose of 24 mg MEDI6012 on Day 1.

Group Type EXPERIMENTAL

MEDI6012

Intervention Type BIOLOGICAL

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

MEDI6012 80 mg IV

Participants received a single IV dose of 80 mg MEDI6012 on Day 1.

Group Type EXPERIMENTAL

MEDI6012

Intervention Type BIOLOGICAL

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

MEDI6012 240 mg IV

Participants received a single IV dose of 240 mg MEDI6012 on Day 1.

Group Type EXPERIMENTAL

MEDI6012

Intervention Type BIOLOGICAL

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

MEDI6012 800 mg IV

Participants received a single IV dose of 800 mg MEDI6012 on Day 1.

Group Type EXPERIMENTAL

MEDI6012

Intervention Type BIOLOGICAL

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

MEDI6012 80 mg SC

Participants received a single SC dose of 80 mg MEDI6012 on Day 1.

Group Type EXPERIMENTAL

MEDI6012

Intervention Type BIOLOGICAL

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

Placebo Intravenous (IV)

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

Group Type PLACEBO_COMPARATOR

Placebo IV

Intervention Type BIOLOGICAL

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

MEDI6012 600 mg SC

Participants received a single SC dose of 600 mg MEDI6012 on Day 1.

Group Type EXPERIMENTAL

MEDI6012

Intervention Type BIOLOGICAL

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

Placebo Subcutaneous (SC)

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

Group Type PLACEBO_COMPARATOR

Placebo SC

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MEDI6012

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

Intervention Type BIOLOGICAL

Placebo SC

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

Intervention Type BIOLOGICAL

Placebo IV

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Men and women 40 - 75 years old
* History of Stable CAD
* Currently receiving statin as standard of care

Exclusion Criteria

* Severe angina pectoris symptoms
* High-risk coronary or carotid artery disease that will likely require surgical or percutaneous intervention during the study period
* Hospitalization for heart failure within 12 months prior to screening
* Uncontrolled Hypertension
* Within 6 months prior to screening, a history of ACS or hospitalization for heart failure
* Clinically significant abnormalities in rhythm, conduction or morphology of ECG
* Subjects with transplanted heart, left ventricular assist device, implanted pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy
* Untreated life-threatening ventricular arrhythmias
* History, within 12 months prior to screening, of myocarditis or restrictive pericarditis, or hemodynamically significant valvular hear disease or aortic disease
* Undergone major surgery with in 3 months prior to screening or has planned major surgery during the study period

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No