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

NCT03004638 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-12-19

Study results available
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Summary

To evaluate the safety pharmacokinetics, and pharmacodynamics of repeat weekly dosing of MEDI6012 in subjects with stable atherosclerosis.

Conditions

Interventions

DRUG

MEDI6012 40 mg

Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.

DRUG

Placebo

Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.

DRUG

MEDI6012 120 mg

Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.

DRUG

MEDI6012 300 mg

Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.

DRUG

Placebo IV Push

Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.

DRUG

MEDI6012 IV Push

Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-01-23
Primary Completion
2017-11-02
Completion
2017-11-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT03004638 on ClinicalTrials.gov