A Dose-Escalation Study of RO7875913 in Healthy Participants

NCT07342114 | Recruiting Phase 1

• 1 other identifier: GO46451
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Adverse Events (AEs)

  Up to approximately 3 months

Secondary Outcomes (4)

• 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

• Observed Value of Pharmacodynamic Markers

  Baseline, up to approximately 3 months

Study Arms (2)

RO7875913

EXPERIMENTAL

Participants will receive RO7875913.

Drug: RO7875913

Placebo

PLACEBO COMPARATOR

Participants will receive Placebo.

Drug: Placebo

Interventions

Placebo DRUG

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

Placebo

RO7875913 DRUG

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

RO7875913

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (1)

New Zealand Clinical Research - Christchurch

Christchurch, Canterbury, 8011, New Zealand

RECRUITING

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

888-662-6728 (U.S. and Canada); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 15, 2026
• Study Start: March 11, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)