Actively Recruiting
Phase 1 Study of RO7875913 to Test Safety and How the Drug Works in Healthy Adults Aged 18 to 65
Led by Genentech, Inc. · Updated on 2026-07-20
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial evaluates the safety, pharmacokinetics, and pharmacodynamics of the drug RO7875913 in healthy adult volunteers aged 18 to 65 years. The study is designed as a Phase I dose-escalation trial to understand how the drug behaves in the body and its potential effects, involving both RO7875913 and placebo treatments. Participants are healthy individuals without major medical conditions, providing a controlled setting to assess the investigational drug. Participants are randomly assigned to receive either RO7875913 or a placebo in a sequential dose-escalation manner. The study uses quadruple masking to ensure unbiased assessment. Dosage and administration schedules follow the protocol, with detailed monitoring of drug concentration and immune response markers during treatment. This study includes a period of up to approximately three months for safety and pharmacodynamic evaluations. Throughout the trial, participants undergo assessments including monitoring for adverse events, blood tests to measure drug levels and antibody responses, and pharmacodynamic marker evaluations. Researchers closely track safety outcomes and determine recommended doses for future studies. Participation involves regular visits for dosing and evaluations, lasting up to three months in total, ensuring careful observation of participants health and response to the study drug.
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 greater than 40 kilogram (kg) with a body mass index of 18-30 kg per meter square (kg/m²)
- Age between 18 and 65 years
- Healthy volunteers without significant medical conditions
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 prior to initiation of study drug
- Treatment with investigational non-biologic therapy (or blinded comparator) within 28 days or 5 drug elimination half-lives prior to initiation of study drug
- Treatment with any immunosuppressive medication within 28 days or 5 drug elimination half-lives prior to initiation of study drug
Research Team
R
Reference Study ID Number: GO46451 https://forpatients.roche.com/ No email attachments.
F
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
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