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

NCT03351738 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2020-03-23

Study results available
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Summary

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

Conditions

  • Stable Coronary Heart Disease

Interventions

DRUG

MEDI5884

Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.

DRUG

Placebo

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

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Michael J Koren, MD, FACC · Jacksonville Center For Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-13
Primary Completion
2018-11-09
Completion
2018-11-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03351738 on ClinicalTrials.gov