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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Intravenous, Open-label, Single-dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of rhLCAT in Subjects With Coronary Artery Disease

Brief 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.

Detailed Summary: After signing informed consent, subjects entered into the trial will be followed for up to 8 weeks which includes: up to 4 weeks screening, entry criteria assessments on Day 0 and single-dose IV infusion on Day 1, and 4 weeks of follow-up.
Sponsor: Alphacore Pharma, LLC

Current Primary Outcome: Summary of Participants Experience with Safety and Tolerability [ Time Frame: Day 1 to Day 28 ]

Safety and tolerability of a single dose of ACP-501 as determined by adverse event reporting, clinical laboratory results, vital signs, physical examination, and electrocardiograms (ECGs).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pharmacokinetic profile [ Time Frame: Hours 0, 1, 6, 12, 24, 48, 72, 96, 168 ]
  • Change in High-Density Lipoprotein-Cholesterol (HDL-C) value following a single dose [ Time Frame: Hours 0, 1, 6, 12, 24, 48, 72, 96, 168 ]


Original Secondary Outcome: Same as current

Information By: Alphacore Pharma, LLC

Dates:
Date Received: March 13, 2012
Date Started: March 2012
Date Completion:
Last Updated: January 10, 2013
Last Verified: January 2013