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New treatment option for Stable Coronary Artery Disease
Official title A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease
ClinicalTrials.gov ID: NCT07495813
What this study is testing
What is RO7763505?
RO7763505 is an investigational medicine, being studied as a potential treatment for stable coronary artery disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Part 1:
- Healthy biologically male and female participants of nonchildbearing potential or childbearing potential with no clinically relevant findings on...
- 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...
You likely can't join if
- Part 1:
- Any condition or disease detected during the medical interview/physical examination that would render the participant unsuitable for the study, place...
- 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...
- Positive result on human immunodeficiency virus (HIV)-1 and HIV-2, hepatitis B virus (HBV) (either hepatitis B surface antigen [HBsAg] or hepatitis B...
- Individuals with New York Heart Association (NYHA) Class III or IV heart failure
- Known or suspected immunocompromised state
See the full eligibility 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...
- 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...
- 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 \ 120 ms, the QTcF will be calculated as: QTcF - (QRS - 100 ms)
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Groningen, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Groningen, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.