A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease
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
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
Treatments tested in this trial
- RO7763505
- Placebo
Treatment groups
196 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov