AzTrials
AzTrials

Stable Coronary Artery DiseasePhase 1NCT07495813

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

A Phase 1 study testing RO7763505 in people with Stable Coronary Artery Disease and Healthy Volunteers, run by Hoffmann-La Roche at 1 site in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
What is being tested?
RO7763505
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
196 participants
Where
1 siteNetherlands
Study dates
31 Mar 2026to 30 Oct 2026
Phase
Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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 screening with no planned changes or scheduled interventions during the study
  • QTc of <= 450 milliseconds (ms) as determined by a single 12-lead ECG recording. If the initial ECG result of the triplicate is exclusionary, consecutive repeat ECG results must be within the acceptable limits. In participants with a stable bundle branch block where the QRS duration is > 120 ms, the QTcF will be calculated as: QTcF - (QRS - 100 ms)

Who cannot join

  • Part 1:
  • Any condition or disease detected during the medical interview/physical examination that would render the participant unsuitable for the study, place the participant at undue risk, or interfere with the ability of the participant to complete the study in the opinion of the Investigator
  • Vaccination within 28 days prior to Day 1 (non-live vaccines including influenza vaccination are permitted 14 days prior to Day 1) or planned before the end of the study. Investigators are advised to review the immunization status of participants who are considered for treatment with RO7763505 and follow local/national guidance for adult vaccination against infectious disease as they deem relevant
  • Positive result on human immunodeficiency virus (HIV)-1 and HIV-2, hepatitis B virus (HBV) (either hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]), hepatitis C virus (HCV) antibody test, or tuberculosis (TB)
  • Part 2:
  • Individuals with New York Heart Association (NYHA) Class III or IV heart failure
  • Known or suspected immunocompromised state
  • Treatment with any investigational therapy within 28 days or within five drug-elimination half-lives (whichever is longer; or longer than either if required by local regulations; if the half-life is unknown, the 90-day period applies) prior to Day 1, calculated from the day of the follow-up from the previous study

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • ICON Plc (LPRA) - Netherlands

    Groningen, 9728 NZ

Other trials in Netherlands

About this study

Official title: A Phase I, Randomized, Double-Blind, Adaptive, Placebo-Controlled, Single- Ascending Dose and Multiple-Ascending Dose, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of RO7763505 Following Oral Administration in Healthy Participants and Patients With Stable Coronary Artery Disease

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).

Being tested
RO7763505, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RO7763505Drug

    Participants will receive RO7763505 as per the schedule described in the protocol.

  • PlaceboDrug

    Participants will receive matching placebo as per the schedule described in the protocol.

Study groups in NCT07495813
Study groupRoleWhat they receive
Part 1: SAD, MAD, and Food Effect in Healthy ParticipantsExperimentalHealthy participants will receive RO7763505 or matching placebo.
Receives: Drug: RO7763505; Drug: Placebo
Part 2: In Stable CAD ParticipantsExperimentalParticipants with stable CAD will receive RO7763505 or matching placebo.
Receives: Drug: RO7763505; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1a and Part 1b: Percentage of Participants With Adverse Events (AEs)

    Measured: Part 1a: Approximately up to 2 Weeks; Part 1b: Approximately up to 3 Weeks

  2. Part 1c: Plasma Concentration of RO7763505 in Fasted and fed State

    Measured: Approximately up to 3 Weeks

  3. Part 2: Percentage of Participants With AEs

    Measured: Approximately up to 6 Weeks

Secondary outcomes (5)

  1. Part 1a and Part 1b: Plasma Concentration of RO7763505 and its Metabolites

    Measured: Part 1a: Approximately up to 2 Weeks; Part 1b: Approximately up to 3 Weeks

  2. Part 1a and Part 1b: Percentage Change From Baseline in Inhibition of Ex Vivo-Stimulated Interleukin-1 Beta ( IL-1β)

    Measured: Part 1a: Baseline, Approximately up to 2 Weeks; Part 1b: Baseline, Approximately up to 3 Weeks

  3. Part 1c: Percentage of Participants With AEs

    Measured: Approximately up to 3 Weeks

  4. Part 2: Plasma Concentration of RO7763505 and its Metabolites

    Measured: Approximately up to 6 Weeks

  5. Part 2: Percentage Change From Baseline in Inhibition of Ex Vivo-Stimulated IL-1β

    Measured: Baseline, Approximately up to 6 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start31 Mar 2026
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
196 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07495813
Sponsor's protocol ID
BP46355
Other IDs
2025-524693-42-00, 2025
Status last verified
Sep 2026
First submitted
11 Mar 2026
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in