A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease

MedImmune

Status and phase: Completed; Phase 2

Conditions: Stable Coronary Heart Disease

Treatments: Drug: Placebo; Drug: MEDI5884

Study type: Interventional

Funder types: Industry

Identifiers

NCT03351738

D7870C00002

Details and patient eligibility

About

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Adults With Stable Coronary Heart Disease.

Full description

A Randomized, Double-blind, Placebo-controlled, Parallel-designed Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Effects of MEDI5884 in Participants with Stable Coronary Heart Disease.

Enrollment: 133 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of stable coronary heart disease prior to screening
• Currently receiving high intensity statin(s)

Exclusion criteria

• Unstable cardiovascular conditions
• Any planned arterial revascularizations
• Fasting Laboratory values at screening: Triglycerides > 500 mg/dl, Low Density Lipoprotein-Cholesterol > 100 mg/dL
• Any disease or condition or laboratory value that would place the participant at an unacceptable risk.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

133 participants in 6 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive subcutaneous (SC) dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.

Treatment:

Drug: Placebo

MEDI5884 50 mg

Experimental group

Description:

Participants will receive SC dose of MEDI5884 50 mg on Days 1, 31, and 61.

Treatment:

Drug: MEDI5884

MEDI5884 100 mg

Experimental group

Description:

Participants will receive SC dose of MEDI5884 100 mg on Days 1, 31, and 61.

Treatment:

Drug: MEDI5884

MEDI5884 200 mg

Experimental group

Description:

Participants will receive SC dose of MEDI5884 200 mg on Days 1, 31, and 61.

Treatment:

Drug: MEDI5884

MEDI5884 350 mg

Experimental group

Description:

Participants will receive SC dose of MEDI5884 350 mg on Days 1, 31, and 61.

Treatment:

Drug: MEDI5884

MEDI5884 500 mg

Experimental group

Description:

Participants will receive SC dose of MEDI5884 500 mg on Days 1, 31, and 61.

Treatment:

Drug: MEDI5884