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

NCT07495813 | Recruiting Phase 1

• 2 other identifiers: BP463552025-524693-42-00
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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. In Part 2, the safety, tolerability, PK and PD of multiple doses of RO7763505 in participants with stable coronary artery diseases (CAD).

Conditions

Stable Coronary Artery Disease; Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

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

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

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

  Approximately up to 3 Weeks

• Part 2: Percentage of Participants With AEs

  Approximately up to 6 Weeks

Secondary Outcomes (5)

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

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

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

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

• Part 1c: Percentage of Participants With AEs

  Approximately up to 3 Weeks

• Part 2: Plasma Concentration of RO7763505 and its Metabolites

  Approximately up to 6 Weeks

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

  Baseline, Approximately up to 6 Weeks

Study Arms (2)

Part 1: SAD, MAD, and Food Effect in Healthy Participants

EXPERIMENTAL

Healthy participants will receive RO7763505 or matching placebo.

Drug: RO7763505; Drug: Placebo

Part 2: In Stable CAD Participants

EXPERIMENTAL

Participants with stable CAD will receive RO7763505 or matching placebo.

Drug: RO7763505; Drug: Placebo

Interventions

RO7763505 DRUG

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

Part 1: SAD, MAD, and Food Effect in Healthy Participants; Part 2: In Stable CAD Participants

Placebo DRUG

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

Part 1: SAD, MAD, and Food Effect in Healthy Participants; Part 2: In Stable CAD Participants

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

ICON Plc (LPRA) - Netherlands

Groningen, 9728 NZ, Netherlands

RECRUITING

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: BP46355 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. and Canada); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Parts 1a, 1b, and 2: Double blind Part 1c: Open-label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 27, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): February 15, 2028
• Study Completion (Estimated): February 15, 2028
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)