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Phase 1
Age: 18Years - 75Years
All Genders
Healthy Volunteers
ID07495813

Phase 1 Study to Test Safety, Effects, and How RO7763505 Works in Healthy Adults and People With Stable Coronary Artery Disease

Led by Hoffmann-La Roche · Updated on 2026-08-11

196

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the safety, tolerability, pharmacokinetics how the drug moves in the body, and pharmacodynamics how the drug affects the body of RO7763505. This study includes healthy adults and people with stable coronary artery disease CAD. It is a Phase 1, randomized, double-blind, placebo-controlled trial designed to evaluate single and multiple doses of the drug, as well as the effect of food on its absorption. The study is divided into parts Part 1 involves healthy participants receiving single ascending doses, multiple ascending doses, and a food effect assessment of RO7763505 or placebo. Part 2 involves participants with stable CAD receiving multiple doses of RO7763505 or placebo. The drug is given orally according to the protocol schedule, with matching placebo given to control groups. Participants will undergo safety monitoring, including physical exams, vital signs, ECGs, blood tests, and urine tests. Researchers will measure adverse events, drug concentrations in plasma, and effects on inflammatory markers like interleukin-1 beta IL-1. The study includes follow-up periods of up to 6 weeks depending on the part. Overall participation lasts several weeks during which participants attend scheduled visits for assessments and monitoring.

CONDITIONS

Brief Title

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

Research Team

R

Reference Study ID Number: BP46355 https://forpatients.roche.com/ No attachments to email below.

F

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

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