A Dose-Escalation Study of RO7875913 in Healthy Participants

NCT ID: NCT07342114

Last Updated: 2026-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-03

Study Completion Date

2026-12-31

Brief Summary

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The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of RO7875913 in healthy participants.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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RO7875913

Participants will receive RO7875913.

Group Type EXPERIMENTAL

RO7875913

Intervention Type DRUG

Participants will receive RO7875913 as per the schedule described in the protocol.

Placebo

Participants will receive Placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will receive placebo as per the schedule described in the protocol.

Interventions

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RO7875913

Participants will receive RO7875913 as per the schedule described in the protocol.

Intervention Type DRUG

Placebo

Participants will receive placebo as per the schedule described in the protocol.

Intervention Type DRUG

Eligibility Criteria

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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 immunodeficiency virus (HIV) antibody screen
* History of any malignancy
* Major surgical procedure within 28 days prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
* History or clinical manifestations of significant metabolic, hepatic, renal, pulmonary, cardiovascular, hematologic, gastrointestinal, urologic, neurologic, or psychiatric disorders
* Known allergy or hypersensitivity to any component of the RO7875913 formulation
* Treatment with investigational biologic therapy (or blinded comparator) within 90 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug
* Treatment with investigational non-biologic therapy (or blinded comparator) within 28 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug
* Treatment with any immunosuppressive medication within 28 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

Central Contacts

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Reference Study ID Number: GO46451 https://forpatients.roche.com/

Role: CONTACT

888-662-6728 (U.S. and Canada)

Other Identifiers

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GO46451

Identifier Type: -

Identifier Source: org_study_id

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