Actively Recruiting
A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease
Led by Hoffmann-La Roche · Updated on 2026-04-20
196
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adult men and women (non-childbearing potential or childbearing potential) with no relevant health issues at screening
- No signs of cognitive impairment or dementia
- Adults with prior myocardial infarction before screening
- Adults with imaging evidence of coronary artery disease (CT or invasive angiography)
- Adults who had PCI or CABG more than 6 months before screening
- Adults diagnosed with stable CAD on stable guideline-directed medical therapy for at least 90 days with no planned changes
- QTc interval less than or equal to 450 milliseconds on ECG (with special calculation for certain heart conditions)
You will not qualify if you...
- Any medical condition or disease making participation unsafe or unsuitable
- Vaccination within 28 days before Day 1 (except non-live vaccines 14 days prior)
- Positive tests for HIV-1, HIV-2, hepatitis B, hepatitis C, or tuberculosis
- NYHA Class III or IV heart failure
- Known or suspected weakened immune system
- Treatment with any investigational drug within 28 days or five drug half-lives before Day 1 (whichever is longer)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
ICON Plc (LPRA) - Netherlands
Groningen, Netherlands, 9728 NZ
Actively Recruiting
Research Team
R
Reference Study ID Number: BP46355 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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