Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT07495813

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

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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)
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

ICON Plc (LPRA) - Netherlands

Groningen, Netherlands, 9728 NZ

Actively Recruiting

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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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