What this study is
This study will evaluate the safety, pharmacokinetics (PK), and activity of single and multiple doses of RO7890597 compared with placebo in healthy volunteers. The study includes single ascending dose (SAD) stage, multiple ascending dose (MAD) stage, food-effect and proton pump inhibitor (PPI) stages, and a supplemental drug-drug interaction (DDI) stage.
What's being tested
- RO7890597
Intervention · DRUG
Participants will receive RO7890597 as per the schedule described in the protocol.
- Placebo
Intervention · DRUG
Participants will receive matching placebo as per the schedule described in the protocol.
- Rabeprazole
Intervention · DRUG
Participants will receive rabeprazole as per the schedule described in the protocol.
- Itraconazole
Intervention · DRUG
Participants will receive itraconazole as per the schedule described in the protocol.
Study details
- Official title
- A Phase I Study to Evaluate the Safety and Pharmacokinetics of RO7890597 Following Single and Multiple Ascending Doses, and the Effects of Food, Proton-Pump Inhibition, And CYP3A Inhibition in Healthy Adult Volunteers
- Sponsor
- Genentech, Inc.
- Conditions
- Healthy Volunteers
- Enrolling
- 139 people
- Starts
- 2026-08-28
- Est. completion
- 2027-06-08
- Design
- Double-blind, randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- Agreement to adhere to the contraception requirements.
- Body mass index of 18 to 30 kilograms per square meter (kg/m²).
You can't join if
- Pregnant, breastfeeding, or intending to become pregnant during the study or required contraception period.
- Treatment with investigational biologic therapy within 90 days or 5 elimination half-lives, whichever is longer, before study drug initiation.
- Treatment with investigational non-biologic therapy within 28 days or 5 elimination half-lives, whichever is longer, before study drug initiation.
- Treatment with immunosuppressive medication within 28 days or 5 elimination half-lives, whichever is longer, before study drug initiation.
- Treatment with any vaccine within 14 days prior to initiation of study drug, or within 28 days for a live or live attenuated vaccine.
- Poor peripheral venous access.
- Major surgery within 28 days before study drug initiation or planned major surgery during the study.
- Current infection or recent infection requiring antibiotics as defined in the protocol.
- History of malignancy within 5 years before screening, except for specified adequately treated cancers.
- History of clinically significant drug or food allergy.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openICON (LPRA) - Lenexa
Lenexa, Kansas, United States
Recruiting
Study team
Sponsor
Genentech, Inc.
Study ID GA46708
Study director
Clinical Trials
Genentech, Inc.
CONTACT
Reference Study ID Number: GA46708 https://forpatients.roche.com/ No attachments to email below.
CONTACT
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.