Ignite Creation Date:
2024-05-06 @ 12:20 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01554800
Status:
COMPLETED
Last Update Posted:
2019-03-14
First Post:
2012-03-13
Brief Title:
Effect of ACP-501 on Safety Tolerability Pharmacokinetics and Pharmacodynamics in Subjects With Coronary Artery Disease
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 12-H-0092 | OTHER | NIH | None |