A Phase I, Randomized, Double-Blind, Adaptive, Placebo-Controlled Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of RO7763505 in Healthy Adults and Patients With Stable Coronary Artery Disease

What this Trial Is About

Researchers are evaluating the safety, tolerability, and how the body processes and responds to the drug RO7763505 in both healthy adults and adults with stable coronary artery disease (CAD). The study includes single and multiple doses, as well as the effect of food on the drug, aiming to better understand its pharmacokinetics and pharmacodynamics. This is a Phase 1 trial led by Hoffmann-La Roche to explore these aspects in a controlled, randomized, and double-blind setting. The study has two main parts: Part 1 involves healthy participants receiving either RO7763505 or a placebo in single ascending doses, multiple ascending doses, and assessing food effects. Part 2 involves participants with stable CAD receiving multiple doses of RO7763505 or placebo. Treatments are given orally according to the protocol, and the study uses a placebo control to compare effects. Participants will be monitored throughout the study for adverse events, drug levels in the blood, and the drug's impact on specific immune markers. Safety and tolerability will be assessed over periods ranging from about two to six weeks depending on the study part. The study includes detailed medical evaluations, ECGs, lab tests, and questionnaires to track how participants respond to the drug and monitor for potential side effects. Total participation time varies by study part, with close follow-up to ensure safety.

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