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RO7875913

Phase 1

Healthy Volunteers | Small molecule | Other |Roche Holding AG|Last Updated: Jul 20, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

RO7875913 · 1 trial · 1 indication

Phase 1 1
NCT07342114A Dose-Escalation Study of RO7875913 in Healthy ParticipantsHealthy Volunteers
RECRUITING40 Analytics
PHASE1RECRUITING
A Dose-Escalation Study of RO7875913 in Healthy Participants
Healthy Volunteers
NCT0734211440
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Study Endpoints

Primary Endpoints

Percentage of Participants with Adverse Events (AEs)
Up to approximately 3 months

Secondary Endpoints

Serum concentration of RO7875913
Up to Day 76
Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7875913 at Baseline and with ADAs to RO7875913 During the Treatment Period
Baseline, Up to Day 76
Recommended Phase II Dose (RP2D) of RO7875913
Up to approximately 3 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RO7875913EXPERIMENTALParticipants will receive RO7875913.
PlaceboPLACEBO_COMPARATORParticipants will receive Placebo.

Interventions

NameTypeDescription
RO7875913DRUGParticipants will receive RO7875913 as per the schedule described in the protocol.
PlaceboDRUGParticipants will receive placebo 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 weight \> 40 kilogram (kg) with a body mass index of 18-30 kg per meter square (kg/m\^2) Exclusion Criteria: * Positive test result for hepatitis B surface antigen, hepatitis C virus (HCV), or human immunodeficienc...

Countries:New Zealand
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Recent Changes (Last 90 Days)

LOWJul 20, 2026NCT07342114lastUpdatePostDate: changed
LOWJul 20, 2026NCT07342114lastUpdatePostDate: changed

Frequently asked questions about RO7875913

What is RO7875913?

RO7875913 is an investigational small molecule being developed by Roche Holding AG (ticker: RHHBY). It is currently in Phase 1 clinical development for use in healthy volunteers. The drug is being studied in a dose-escalation trial to evaluate its safety and tolerability.

What is RO7875913 used for?

RO7875913 is being studied for use in healthy volunteers. It is an investigational small molecule in Phase 1 clinical development. The current trial is a dose-escalation study designed to assess the drug's safety, tolerability, and pharmacokinetics in healthy participants.

Who makes RO7875913?

RO7875913 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting a Phase 1 clinical trial of this investigational small molecule in healthy volunteers.

What phase is RO7875913 in?

RO7875913 is in Phase 1 clinical development. It is an investigational small molecule being studied in a dose-escalation trial in healthy volunteers. The drug is not yet approved and is still in early-stage clinical testing.

What clinical trials is RO7875913 in?

RO7875913 is being studied in one Phase 1 clinical trial, NCT07342114, titled "A Dose-Escalation Study of RO7875913 in Healthy Participants." This trial is currently recruiting and aims to enroll 40 participants in New Zealand. The study is randomized, double-blind, and placebo-controlled.

Is RO7875913 FDA approved?

RO7875913 is not FDA approved. It is an investigational small molecule currently in Phase 1 clinical development. The drug is being studied in a dose-escalation trial in healthy volunteers to evaluate its safety and tolerability, but it has not yet received regulatory approval.