A Randomized, Double-Blind, Placebo-Controlled, Exploratory Study on the Safety, Tolerability, and Pharmacodynamics of IMB-1018972 in Subjects With Angina Due to Obstructive Coronary Artery Disease

IMB101-006

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

2021-04-23

2023-09-21

2023-09-21

Completed

Early phase I

58

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 58, 'type': 'ACTUAL'}}

2024-04-23