A Dose-Escalation Study of RO7875913 in Healthy Participants

May 22, 2026 updated by: Genentech, Inc.

A Phase I Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of RO7875913 in Healthy Volunteers

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • New Zealand
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8011
        • Recruiting
        • New Zealand Clinical Research - Christchurch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive Placebo.
Drug: Placebo
Participants will receive placebo as per the schedule described in the protocol.
Experimental: RO7875913
Participants will receive RO7875913.
Drug: RO7875913
Participants will receive RO7875913 as per the schedule described in the protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Adverse Events (AEs)
Time Frame: Up to approximately 3 months
Up to approximately 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum concentration of RO7875913
Time Frame: Up to Day 76
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
Time Frame: Baseline, Up to Day 76
Baseline, Up to Day 76
Recommended Phase II Dose (RP2D) of RO7875913
Time Frame: Up to approximately 3 months
Up to approximately 3 months
Observed Value of Pharmacodynamic Markers
Time Frame: Baseline, up to approximately 3 months
Baseline, up to approximately 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • GO46451

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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