Testing RO7890597 safety and how it moves through the body in healthy adults
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
Run by Genentech, Inc. · NCT07797478 · Data updated 2026-11-12
This study tests RO7890597 against placebo in healthy adults to see its safety, how it behaves in the body, and any activity at different doses.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 139 (estimated) |
| Sponsor | Genentech, Inc. Industry-sponsored |
| Locations | 1 site (Lenexa, Kansas) |
| Status | Recruiting |
| Started | August 28, 2026 |
| Main results expected | June 8, 2027 |
| Study ends | June 8, 2027 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT07797478 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults with BMI 18–30 kg/m2 who agree to contraception requirements and meet all inclusion/exclusion criteria.
✕Probably not a fit
Healthy individuals who do not have the condition or who may not benefit from testing a drug in healthy volunteers, or who do not meet eligibility.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1 interventional trial in healthy volunteers. It uses single ascending doses and multiple ascending doses to explore safety and pharmacokinetics, with additional arms to examine the effects of food and proton pump inhibitors, plus a drug-drug interaction assessment. Participants may receive RO7890597 or placebo, with monitoring for adverse events and changes in drug levels. The study is conducted at a single site in Lenexa, Kansas, led by Genentech."
Why it matters
Potential benefit: If successful, participants may contribute to understanding the drug's safety and dosing, which could support future trials.
How similar studies have gone: Prior Phase 1 studies with similar designs have helped establish safety and PK profiles for new drugs, though results can vary by compound.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Agreement to adhere to the contraception requirements. * Body mass index of 18 to 30 kilograms per square meter (kg/m²). Exclusion Criteria: * 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.
Where it's running
-
ICON (LPRA) - Lenexa
Lenexa, Kansas, United States Recruiting
Study contacts
- Study coordinator: Reference Study ID Number: GA46708 https://forpatients.roche.com/ No attachments to email below.
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. and Canada)
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.