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

MedImmune

Status and phase: Completed; Phase 2

Conditions: Coronary Artery Disease

Treatments: Biological: Placebo IV; Biological: Placebo SC; Biological: MEDI6012

Study type: Interventional

Funder types: Industry

Identifiers

NCT02601560

D5780C00002

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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48 participants in 8 patient groups, including a placebo group

MEDI6012 24 mg IV

Experimental group

Description:

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

Treatment:

Biological: MEDI6012

MEDI6012 80 mg IV

Experimental group

Description:

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

Treatment:

Biological: MEDI6012

MEDI6012 240 mg IV

Experimental group

Description:

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

Treatment:

Biological: MEDI6012

MEDI6012 800 mg IV

Experimental group

Description:

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

Treatment:

Biological: MEDI6012

MEDI6012 80 mg SC

Experimental group

Description:

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

Treatment:

Biological: MEDI6012

Placebo Intravenous (IV)

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo IV

MEDI6012 600 mg SC

Experimental group

Description:

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

Treatment:

Biological: MEDI6012

Placebo Subcutaneous (SC)

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo SC