Effect of ACP-501 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Subjects With Coronary Artery Disease

Phase 1 Completed 16 enrolled MedImmune LLC National Heart, Lung, and Blood Institute (NHLBI) · collab

NaSingle-groupOpen-labelTreatment

Summary

This study is a phase 1, intravenous, open-label, single-dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-501 (recombinant human Lecithin Cholesterol Acyl Transferase (rhLCAT)) in subjects with coronary artery disease (CAD). Four cohorts consisting of 4 subjects each will receive one dose of ACP-501. The dose will be escalated by cohort.

Timeline

Start: 2012-03
Primary completion: 2012-09
Completion: 2012-09

Publications

Shamburek RD, Bakker-Arkema R, Shamburek AM, Freeman LA, Amar MJ, Auerbach B, Krause BR, Homan R, Adelman SJ, Collins HL, Sampson M, Wolska A, Remaley AT. Safety and Tolerability of ACP-501, a Recombinant Human Lecithin:Cholesterol Acyltransferase, in a Phase 1 Single-Dose Escalation Study. Circ Res. 2016 Jan 8;118(1):73-82. doi: 10.1161/CIRCRESAHA.115.306223. Epub 2015 Dec 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	recombinant human Lecithin Cholesterol Acyl Transferase	Protein / enzyme biologic	0.9 mg/kg	Intravenous
Subject	recombinant human Lecithin Cholesterol Acyl Transferase	Protein / enzyme biologic	3 mg/kg	Intravenous
Subject	recombinant human Lecithin Cholesterol Acyl Transferase	Protein / enzyme biologic	9 mg/kg	Intravenous
Subject	recombinant human Lecithin Cholesterol Acyl Transferase	Protein / enzyme biologic	13.5 mg/kg	Intravenous

Effect of ACP-501 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Subjects With Coronary Artery Disease

Summary

Timeline

Publications

Drugs

Indications