Recent Updates
Recently added Catalysts

RO7763505

Phase 1

Stable Coronary Artery Disease | Small molecule | Cardiovascular |Roche Holding AG|Trials Updated: Sep 8, 2026

RO7763505 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment196

FDA Designations

No designations recorded

RO7763505 clinical trials

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
ACTIVE NOT_RECRUITING196 Analytics
PHASE1ACTIVE NOT_RECRUITING
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
Unlock Study Endpoints

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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

MEDIUMSep 8, 2026NCT07495813Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMSep 8, 2026NCT07495813Status: RECRUITING → ACTIVE_NOT_RECRUITING
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 developed for stable coronary artery disease. It is currently in Phase 1 clinical development, with a study evaluating its effects and safety in healthy people and people with stable heart disease.

Who makes RO7763505?

RO7763505 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting a Phase 1 clinical trial to evaluate the drug's safety and how it works in participants.

What phase is RO7763505 in?

RO7763505 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 1 study is currently active but not recruiting participants.

What clinical trials is RO7763505 in?

RO7763505 is being studied in one active Phase 1 clinical trial with the identifier NCT07495813. The trial is a randomized, double-blind, controlled study enrolling 196 participants, including healthy volunteers and people with stable coronary artery disease, conducted in the Netherlands.

Is RO7763505 the same as any other drug?

No alternative names for RO7763505 have been identified. The drug is known by its development code RO7763505 and is being investigated by Roche for stable coronary artery disease.