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RO7763505

Phase 1

Stable Coronary Artery Disease | Small molecule | Cardiovascular |Roche Holding AG|Last Updated: Aug 11, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment196

FDA Designations

No designations recorded

Clinical trial landscape

RO7763505 · 1 trial · 2 indications

Phase 1 1
NCT07495813A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart DiseaseStable Coronary Artery Disease
RECRUITING196 Analytics
PHASE1RECRUITING
A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease
Stable Coronary Artery DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1a and Part 1b: Percentage of Participants With Adverse Events (AEs)
Part 1a: Approximately up to 2 Weeks; Part 1b: Approximately up to 3 Weeks
Part 1c: Plasma Concentration of RO7763505 in Fasted and fed State
Approximately up to 3 Weeks
Part 2: Percentage of Participants With AEs
Approximately up to 6 Weeks

Secondary Endpoints

Part 1a and Part 1b: Plasma Concentration of RO7763505 and its Metabolites
Part 1a: Approximately up to 2 Weeks; Part 1b: Approximately up to 3 Weeks
Part 1a and Part 1b: Percentage Change From Baseline in Inhibition of Ex Vivo-Stimulated Interleukin-1 Beta ( IL-1β)
Part 1a: Baseline, Approximately up to 2 Weeks; Part 1b: Baseline, Approximately up to 3 Weeks
Part 1c: Percentage of Participants With AEs
Approximately up to 3 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: SAD, MAD, and Food Effect in Healthy ParticipantsEXPERIMENTALHealthy participants will receive RO7763505 or matching placebo.
Part 2: In Stable CAD ParticipantsEXPERIMENTALParticipants with stable CAD will receive RO7763505 or matching placebo.

Interventions

NameTypeDescription
RO7763505DRUGParticipants will receive RO7763505 as per the schedule described in the protocol.
PlaceboDRUGParticipants will receive matching placebo as per the schedule described in the protocol.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 surgica...

Countries:Netherlands
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Recent Changes (Last 90 Days)

LOWAug 11, 2026NCT07495813lastUpdatePostDate: changed
LOWAug 11, 2026NCT07495813lastUpdatePostDate: changed

Frequently asked questions about RO7763505

What is RO7763505 used for?

RO7763505 is an investigational small molecule being studied for stable coronary artery disease. It is in Phase 1 clinical development by Roche Holding AG (RHHBY). The drug is being evaluated in a clinical trial that includes both healthy volunteers and people with stable heart disease.

Who makes RO7763505?

RO7763505 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is currently in Phase 1 clinical development for stable coronary artery disease. Roche is conducting a randomized, double-blind, controlled study to evaluate the drug.

What phase is RO7763505 in?

RO7763505 is in Phase 1 clinical development. It is an investigational drug being studied for stable coronary artery disease and has not been approved by regulatory authorities. The ongoing Phase 1 trial is currently recruiting participants.

What clinical trials is RO7763505 in?

RO7763505 is being studied in a Phase 1 clinical trial with the identifier NCT07495813. This randomized, double-blind, controlled study is evaluating how the drug works and how safe it is when given to healthy people and people with stable heart disease. The trial is recruiting in the Netherlands and aims to enroll 196 participants.

Is RO7763505 being studied in healthy volunteers?

Yes, RO7763505 is being studied in healthy volunteers as part of its Phase 1 clinical trial. The study, NCT07495813, includes both healthy volunteers and people with stable coronary artery disease. The trial is recruiting participants aged 18 years and older in the Netherlands.