How RO7763505 works and how safe it is in healthy people and people with stable heart disease

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 will test single and multiple doses of RO7763505 in healthy adults and people with stable coronary artery disease to see if the drug is safe and how the body absorbs and responds to it.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 196 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hoffmann-La Roche (industry)
• Locations: 1 site (Groningen)
• Trial ID: NCT07495813 on ClinicalTrials.gov

What this trial studies

This Phase 1, randomized, placebo-controlled study uses single ascending doses, multiple ascending doses, and a food-effect evaluation in healthy volunteers (Parts 1a–1c) and a multiple-dose regimen in people with stable coronary artery disease (Part 2). Participants receive RO7763505 or placebo and undergo serial safety assessments, pharmacokinetic sampling, and pharmacodynamic measurements. The trial is designed to define tolerability, adverse event profiles, dose-related pharmacokinetics, and early biological effects to inform future dosing. Screening includes medical history, physical exam, ECG, laboratory testing, and for CAD participants, objective imaging or prior revascularization documentation.

Who should consider this trial

Good fit: Ideal candidates are adults who are either healthy volunteers with no clinically significant findings on screening exams or adults with documented stable coronary artery disease who have been on stable guideline-directed medical therapy for at least 90 days and had any PCI/CABG more than six months earlier.

Not a fit: People with unstable or recently changed cardiac conditions, recent myocardial infarction or revascularization within six months, major uncontrolled comorbidities, or those who are pregnant or otherwise ineligible for the protocol may not receive benefit from participation.

Why it matters

Potential benefit: If successful, the study could identify safe dose ranges and how the drug behaves in the body to guide later trials that might determine whether RO7763505 can help people with coronary artery disease.

How similar studies have performed: Early-phase dose-escalation studies of cardiovascular drugs commonly establish safety and pharmacokinetics, but they do not prove clinical benefit, and there are no published Phase 1 results specific to RO7763505.

Eligibility criteria

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

Where this trial is running

Groningen

• ICON Plc (LPRA) - Netherlands — Groningen, Netherlands (RECRUITING)

Study contacts

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

Conditions: Stable Coronary Artery Disease, Healthy Volunteers