Exploratory Study on the Safety, Tolerability, and Pharmacodynamics of IMB-1018972 in Subjects With Angina Due to Obstructive Coronary Artery Disease (IMPROVE-Ischemia)

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and tolerability of IMB-1018972 in subjects with obstructive CAD and inducible ischemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imbria Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Documented history of stable angina (CCS grading I-III) or anginal equivalent for ≥1 month prior to screening

• Ability to safely abstain from beta blockers for 48 hours prior to echo examinations in the opinion of the Investigator

• Preserved LV systolic function, defined as LVEF≥50% by any imaging modality

• Obstructive CAD and recent evidence of stress-induced myocardial ischemia

Exclusion Criteria:

• Women of childbearing potential or who are currently pregnant or breast-feeding

• Clinically indicated for coronary revascularization (PCI/CABG) at time of screening or clinically significant LMS or proximal LAD stenosis likely to warrant revascularization during the study period in the opinion of the investigator.

• Type 1 insulin dependent diabetes mellitus (IDDM)

• Presence of pacemaker, cardiac resynchronization therapy and/or implantable cardioverter defibrillator

• Severe or clinically significant valvular heart disease

• Clinically significant concurrent condition which could prevent the patient from performing any of the protocol-specified assessments, represent a safety concern if the patient participates in the trial or could confound trial assessments of safety or tolerability