RO7875913 dose-escalation in healthy adults

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

This study will test increasing doses of the experimental drug RO7875913 in healthy adults to see how safe it is and how the body processes it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Genentech, Inc. (Industry-sponsored)
• Locations: 1 site (Christchurch, Canterbury)
• Trial ID: NCT07342114 on ClinicalTrials.gov

What this trial studies

This Phase 1, interventional, dose-escalation study gives healthy adult volunteers RO7875913 or placebo and collects safety, pharmacokinetic (PK), and pharmacodynamic (PD) data. Participants are enrolled under inclusion criteria (weight >40 kg, BMI 18–30 kg/m^2, contraception where required) and screened to exclude significant medical problems or positive viral tests. Dosing cohorts escalate after review of safety and PK results, with blood sampling and clinical monitoring performed at scheduled time points. The primary focus is tolerability and how the drug is absorbed, distributed, metabolized, and excreted to inform dosing for later patient studies.

Who should consider this trial

Good fit: Ideal participants are healthy adults who meet the weight and BMI criteria, agree to contraception requirements, have no significant medical history or positive viral screens, and can attend the Christchurch research site.

Not a fit: People with active medical conditions, a history of cancer, positive hepatitis or HIV tests, recent major surgery, known allergy to the drug components, or who do not meet weight/BMI or contraception requirements are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the results could identify safe dose ranges and dosing schedules to support later trials that test whether RO7875913 helps patients with relevant conditions.

How similar studies have performed: Phase 1 dose-escalation studies of novel drugs are a standard and successful approach to define safety and PK/PD, but they do not by themselves demonstrate clinical benefit for patients.

Eligibility criteria

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

Where this trial is running

Christchurch, Canterbury

• New Zealand Clinical Research - Christchurch — Christchurch, Canterbury, New Zealand (Recruiting)

Study contacts

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

Conditions Healthy Volunteers