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

Imbria Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Coronary Artery Disease

Ischemia

Treatments

Drug: Placebo

Drug: IMB-1018972

Study type

Interventional

Funder types

Industry

Identifiers

IMB101-006

Details and patient eligibility

About

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

Enrollment

58 patients

Sex

All

Ages

35 to 75 years old

Volunteers

No Healthy Volunteers

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