Effect of ACP-501 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Subjects With Coronary Artery Disease
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Summary of Participants Experience with Safety and Tolerability [ Time Frame: Day 1 to Day 28 ] [ Designated as safety issue: Yes ]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).
- Pharmacokinetic profile [ Time Frame: Hours 0, 1, 6, 12, 24, 48, 72, 96, 168 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2012|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01554800
|United States, Maryland|
|Cardiovascular and Pulmonary Branch (CPB) of NIH|
|Bethesda, Maryland, United States, 20892|