Health TrialsbyHealthPanel

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

ConditionsStable Coronary Artery DiseaseHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHoffmann-La Roche

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

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

Disqualifiers

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)

Individuals with New York Heart Association (NYHA) Class III or IV heart failure

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

196 Participants
are divided into 2 treatment groups
Group A: Part 1: SAD, MAD, and Food Effect in Healthy ParticipantsExperimental treatment 2 interventions
Group B: Part 2: In Stable CAD ParticipantsExperimental treatment 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov
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