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

NCT ID: NCT01554800

Last Updated: 2019-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-09-30

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.

Conditions

Coronary Artery Disease; Atherosclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACP-501

Group Type: EXPERIMENTAL

ACP-501

Intervention Type: DRUG

A single dose infusion

Interventions

ACP-501

A single dose infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• A history of stable documented CAD
• Currently non-smoking males and females ages 30 to 85 years inclusive.

o Female subjects of child-bearing potential (neither pregnant nor breast-feeding) must be using adequate birth control during study conduct.

• Chronic concomitant medications must be stable for at least 2 months prior to screening
• HDL-C < 50 mg/dL for men and < 55 mg/dL for women
• Body Mass Index (BMI) of approximately 18 to 35 kg/m^2; and a total body weight >= 50 kg (110 lbs) and <= 110 kg (approximately 242 lbs)

Exclusion Criteria

• Myocardial infarction, stroke, or coronary intervention/revascularization procedure within 6 months prior to dosing.
• Chronic heart failure (> New York Heart Association (NYHA) Functional Classification II).
• Ventricular tachyarrhythmias.
• Uncontrolled Type 2 (HbA1c > 8.5%) or Type 1 diabetes mellitus.
• History of febrile illness within 5 days prior to dosing.
• History of regular alcohol consumption exceeding 10 drinks per week.
• 12-lead ECG demonstrating QTc > 500 msec at screening.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cardiovascular and Pulmonary Branch (CPB) of NIH

Bethesda, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26628614 (View on PubMed)

Other Identifiers

12-H-0092

Identifier Type: OTHER

Identifier Source: secondary_id

ACP 501-01

Identifier Type: -

Identifier Source: org_study_id