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RecruitingPhase 1NCT07495813

A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease

Trial Parameters

ConditionStable Coronary Artery Disease
SponsorHoffmann-La Roche
Study TypeINTERVENTIONAL
PhasePhase 1
Enrollment196
SexALL
Min Age18 Years
Max Age75 Years
Start Date2026-03-31
Completion2027-12-31
Interventions
RO7763505Placebo

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Brief Summary

This study will evaluate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses (SAD) (Part 1a), multiple ascending doses (MAD) (Part 1b), and the food effect (Part 1c) of RO7763505 in healthy adult participant. In Part 2, the safety, tolerability, PK and PD of multiple doses of RO7763505 in participants with stable coronary artery diseases (CAD).

Eligibility Criteria

Inclusion Criteria: Part 1: * Healthy biologically male and female participants of nonchildbearing potential or childbearing potential with no clinically relevant findings on physical examination at screening or baseline (assessed either on Day -2 or Day -1), including detailed medical and surgical history, vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology, and urinalysis * No suspicion of cognitive impairment/dementia as judged by the Investigator Part 2: * Myocardial infarction before the screening visit * Objective imaging evidence (coronary computed tomography \[CT\] angiography or invasive angiography) of coronary atherosclerosis Participants who underwent percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) are eligible if the procedure was done \>6 months prior to screening * A diagnosis of stable CAD, defined as being on stable guideline-directed medical therapy (GDMT) if tolerated for at least 90 days prior to screen

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