Actively Recruiting
A Phase I Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of RO7875913 in Healthy Volunteers
Led by Genentech, Inc. · Updated on 2026-05-26
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety, how the body processes, and the effects of the drug RO7875913 in healthy adult volunteers. This Phase I clinical trial aims to better understand the drug's behavior in the body and monitor any side effects or immune responses it may cause. The study is sponsored by Genentech, Inc. and focuses on healthy adults aged 18 to 65 years. Participants will be randomly assigned to receive either the study drug RO7875913 or a placebo. The study uses a dose-escalation design to evaluate different doses of RO7875913. The treatment period lasts up to approximately three months, during which various drug concentrations and immune responses are measured. The study also aims to identify the recommended dose for future studies. During the trial, participants will undergo safety monitoring with assessments for adverse events, blood tests to measure drug levels and immune markers, and evaluations of pharmacodynamic markers. The main outcome is tracking any adverse events up to about three months. Participants will be followed closely throughout the treatment and observation period, which includes laboratory testing up to Day 76. The total participation duration depends on the study schedule and dose escalation.
CONDITIONS
Brief Title
A Dose-Escalation Study of RO7875913 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Agreement to adhere to the contraception requirements
- Body weight over 40 kilogram (kg) with a body mass index of 18-30 kg per meter square (kg/m²)
- Age between 18 and 65 years
- Healthy adult volunteers
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 3 months
Participants receive RO7875913 or placebo according to the study protocol while being monitored for safety, pharmacokinetics, and pharmacodynamics.
Multiple visits during treatment period as per protocol
Trial Site Locations
Total: 1 location
1
New Zealand Clinical Research - Christchurch
Christchurch, Canterbury, New Zealand, 8011
Actively Recruiting
Research Team
R
Reference Study ID Number: GO46451 https://forpatients.roche.com/
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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