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

MedImmune

Status and phase

Completed

Phase 1

Conditions

Coronary Artery Disease

Atherosclerosis

Treatments

Drug: ACP-501

Study type

Interventional

Funder types

Industry

NIH

Identifiers

NCT01554800

ACP 501-01

12-H-0092 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

30 to 85 years old

Volunteers

No Healthy Volunteers

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.