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Recruiting

NCT Number: NCT07495813

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

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Plc (LPRA) - Netherlands

Groningen, 9728 NZ, Netherlands

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

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

Treatment and study plan

RO7763505

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: 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

    Time frame: Approximately up to 3 Weeks

  3. Part 2: Percentage of Participants With AEs

    Time frame: Approximately up to 6 Weeks

Secondary outcomes

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

    Time frame: 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)

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

  3. Part 1c: Percentage of Participants With AEs

    Time frame: Approximately up to 3 Weeks

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

    Time frame: Approximately up to 6 Weeks

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

    Time frame: Baseline, Approximately up to 6 Weeks

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

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

CONTACT

[email protected]

888-662-6728 (U.S. and Canada)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 27, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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