Safety and Efficacy of CMX-2043 in Subjects Undergoing Coronary Reperfusion Therapy

Study Overview
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Brief Summary
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This study is conducted to assess the safety of CMX-2043 solution for intravenous (IV) injection, and to evaluate efficacy on the basis of the changes seen in the cardiac biomarkers and continuous electrocardiography (ECG) monitoring. Additionally, correlation of the levels/changes in the biomarkers and the pharmacokinetic evaluations of the drug will be explored.

Official Title
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A Prospective, Randomized, Comparative, Blinded, Placebo-Controlled, Three Different Intravenous Dose, Phase 2a Study of the Safety and Efficacy of CMX-2043 in Subjects Undergoing PCI and Peri-Operative Reperfusion Treatment (SUPPORT-1)

Conditions
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Stable Coronary Artery Disease, Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: CMX-2043
* Drug: Placebo control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have stable coronary artery disease undergoing elective PCI. Female subjects not of child-bearing potential. Absence of ST segment depression >1.0 mm and absence of ST elevation >1.0 mm in any lead on the baseline 12-lead ECG. subjects with CK-MB and troponin-T levels lower than the upper limit of normal. Subjects free of acute injuries or illnesses. Exclusion Criteria: Subjects with unstable angina (angina at rest, worsening frequency, duration of angina) or other signs of unstable coronary artery disease. Subjects who had had an MI within 14 days prior to the PCI procedure. Subjects with conditions that contraindicate the PCI (e.g. coagulopathy, valvular disease, PVD). Subjects with history of TIA/stroke within 90 days or any intracranial bleed. Subjects with creatinine clearance ≥ 1.5 times the upper limit of normal. Subjects with an active history of psychiatric disorders that is likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements. Subjects with a history of alcohol or drug abuse. Subjects with documented history of human immunodeficiency virus (HIV), or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive. Subjects with uncorrected clinically significant abnormalities of clinical laboratory tests who in the investigators opinion will interfere with the study conduct. Subject with chronic diseases considered by the anesthetist unfit for surgery and/or who in the opinion of the investigator will increase the risk of the study or obscure the interpretation of results. Subjects who have participated in a clinical study within 1 month or are currently participating in a clinical study of an investigational agent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose<br> | Drug: CMX-2043<br>* Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose.<br>|
| Experimental: Mid Dose<br> | Drug: CMX-2043<br>* Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose.<br>|
| Experimental: High Dose<br> | Drug: CMX-2043<br>* Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo control<br>* Vehicle solution for IV administration single dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by changes in CK-MB |  | within 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac biomarkers |  | within 24 hours | 
| ST segment changes |  | within 24 hours |