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RO7890597

Phase 1

Undisclosed | Small molecule | Other |Roche Holding AG|Trials Updated: Oct 16, 2026

RO7890597 development status

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment139

FDA Designations

No designations recorded

RO7890597 clinical trials

RO7890597 · 1 trial · 1 indication

Phase 1 1
NCT07797478A Study of RO7890597 in Healthy Adult VolunteersHealthy Volunteers
RECRUITING139 Analytics
PHASE1RECRUITING
A Study of RO7890597 in Healthy Adult Volunteers
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence and Severity of Adverse Events (AEs)
Up to approximately 12 weeks

Secondary Endpoints

Plasma Concentration of RO7890597
At prespecified timepoints from baseline up to approximately 12 weeks
Plasma Concentration of RO7890597 Under Fasted and Fed Conditions
At prespecified timepoints from baseline up to approximately 12 weeks
Plasma Concentration of RO7890597 Alone and in Combination With Rabeprazole
At prespecified timepoints from baseline up to approximately 12 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
RO7890597EXPERIMENTALParticipants will receive a single or multiple doses of RO7890597 alone, or with rabeprazole or itraconazole.
PlaceboEXPERIMENTALParticipants will receive single or multiple doses of matching placebo.

Interventions

NameTypeDescription
RO7890597DRUGParticipants will receive RO7890597 as per the schedule described in the protocol.
PlaceboDRUGParticipants will receive matching placebo as per the schedule described in the protocol.
RabeprazoleDRUGParticipants will receive rabeprazole as per the schedule described in the protocol.
ItraconazoleDRUGParticipants will receive itraconazole as per the schedule described in the protocol.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Agreement to adhere to the contraception requirements. * Body mass index of 18 to 30 kilograms per square meter (kg/m²). Exclusion Criteria: * Pregnant, breastfeeding, or intending to become pregnant during the study or required contraception period. * Treatment with investi...

Countries:United States
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Recent Changes (Last 90 Days)

LOWOct 16, 2026NCT07797478lastUpdatePostDate: changed
LOWOct 16, 2026NCT07797478lastUpdatePostDate: changed
LOWSep 21, 2026NCT07797478lastUpdatePostDate: changed
LOWSep 21, 2026NCT07797478lastUpdatePostDate: changed
LOWSep 1, 2026NCT07797478NEW_TRIAL: changed
LOWSep 1, 2026NCT07797478NEW_TRIAL: changed

Frequently asked questions about RO7890597

What is RO7890597?

RO7890597 is an investigational small molecule drug being developed by Roche Holding AG. It is currently in Phase 1 clinical development and is being studied in healthy adult volunteers. No therapeutic indication has been disclosed for this compound.

Who is developing RO7890597?

RO7890597 is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating this small molecule compound.

What phase is RO7890597 in?

RO7890597 is in Phase 1 clinical development. It has not been approved by the FDA and remains an investigational drug. The program currently has one active trial, which is recruiting participants.

What clinical trials is RO7890597 in?

RO7890597 is being evaluated in a single Phase 1 trial, NCT07797478, titled A Study of RO7890597 in Healthy Adult Volunteers. The trial is recruiting in the United States and is designed to enroll 139 participants aged 18 years and older.

How is the RO7890597 trial designed?

The Phase 1 trial NCT07797478 is a randomized, double-blind, controlled study of RO7890597 in healthy adult volunteers. It plans to enroll 139 participants of all sexes, aged 18 years and older, at sites in the United States. The study is currently recruiting.