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

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.

Timeline

Start

2015-12-03

Primary completion

2016-08-20

Completion

2016-11-03

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo Intravenous (IV) vs MEDI6012 80 mg IV; p <0.001; ANCOVA NCT02601560 ↗

registry analysis (superiority or other test); Placebo Subcutaneous (SC) vs MEDI6012 80 mg SC; p <0.001; ANCOVA NCT02601560 ↗

registry analysis (superiority or other test); Placebo Intravenous (IV) vs MEDI6012 240 mg IV; p <0.001; ANCOVA NCT02601560 ↗

Publications

• George RT, Abuhatzira L, Stoughton SM, Karathanasis SK, She D, Jin C, Buss NAPS, Bakker-Arkema R, Ongstad EL, Koren M, Hirshberg B. MEDI6012: Recombinant Human Lecithin Cholesterol Acyltransferase, High-Density Lipoprotein, and Low-Density Lipoprotein Receptor-Mediated Reverse Cholesterol Transport. J Am Heart Assoc. 2021 Jul 6;10(13):e014572. doi: 10.1161/JAHA.119.014572. Epub 2021 Jun 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	recombinant human Lecithin Cholesterol Acyl Transferase	Protein / enzyme biologic	24 mg	Intravenous
Subject	recombinant human Lecithin Cholesterol Acyl Transferase	Protein / enzyme biologic	80 mg	Intravenous
Subject	recombinant human Lecithin Cholesterol Acyl Transferase	Protein / enzyme biologic	240 mg	Intravenous
Subject	recombinant human Lecithin Cholesterol Acyl Transferase	Protein / enzyme biologic	600 mg	Intravenous
Subject	recombinant human Lecithin Cholesterol Acyl Transferase	Protein / enzyme biologic	800 mg	Intravenous

Indications