NCT03004638

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

A Phase 2a Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of MEDI6012 in Subjects With Stable Atherosclerotic Cardiovascular Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

A Phase 2a Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of MEDI6012 in Subjects with Stable Atherosclerotic Cardiovascular Disease

Conditions

• Atherosclerosis
• Cardiovascular Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-23
• Primary completion: 2017-11-02
• Completion: 2017-11-02
• First posted: 2016-12-29
• Last updated: 2018-12-19
• Results posted: 2018-11-30

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study