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

NCT02601560 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-03-19

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

MEDI6012

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

BIOLOGICAL

Placebo SC

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

BIOLOGICAL

Placebo IV

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

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-03
Primary Completion
2016-08-20
Completion
2016-11-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02601560 on ClinicalTrials.gov