> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-ro7890597-in-healthy-adult-volunteers-2a743d73-aa10-4793-8227-e2eea3236476 > Record changed: 2026-11-04 # A Study of RO7890597 in Healthy Adult Volunteers NCT07797478 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) Participants 139 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) Lead sponsor Genentech, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) Start date 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) **Short title** A Study of RO7890597 in Healthy Adult Volunteers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) ## Dates **Completion date** 2027-06-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) **First posted** 2026-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) **Registry last updated** 2026-10-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) **Primary completion date** 2027-06-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) **Start date** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) ## Size and sites **Participants** 139 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) **Planned participants** 139 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) **Lead sponsor** Genentech, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) ## Identifiers **Registry ID** NCT07797478 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) **ClinicalTrials.gov ID** NCT07797478 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Basic science **Masking** Double masking **Masking description** SAD and MAD stages: Double Blind Food-effect, PPI, and DDI stages: Open-label **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) ## Outcomes ### Primary outcomes 1. Incidence and Severity of Adverse Events (AEs) Timeframe: Up to approximately 12 weeks ### Secondary outcomes 1. Plasma Concentration of RO7890597 Timeframe: At prespecified timepoints from baseline up to approximately 12 weeks 2. Plasma Concentration of RO7890597 Under Fasted and Fed Conditions Timeframe: At prespecified timepoints from baseline up to approximately 12 weeks 3. Plasma Concentration of RO7890597 Alone and in Combination With Rabeprazole Timeframe: At prespecified timepoints from baseline up to approximately 12 weeks Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) ## Sites - ICON (LPRA) - LenexaLenexa, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) ## References - Related resource (www.gene.com) Source: [www.gene.com](https://www.gene.com/contact-us/submit-medical-inquiry) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07797478) ## Related records ### Drugs (2) - [Itraconazole](https://trialight.com/data/asset/itraconazole-c6f2473e-393a-44a9-8969-8d501b15ef65.md) - [Rabeprazole](https://trialight.com/data/asset/rabeprazole-c1f8c7ed-cc36-469a-a527-ead5eea1412a.md) ### Lead sponsors (1) - [Genentech, Inc.](https://trialight.com/data/company/genentech-inc-36ac9a9c-11fd-490c-a8c8-30c070bd99d2.md) ### Targets (2) - [ATP4A](https://trialight.com/data/target/atp4a-cb311620-cbd7-5592-86bf-6eff6bf5e70e.md) - [ATP4B](https://trialight.com/data/target/atp4b-dd74ece5-dac6-5730-bcb3-d26c200dd49f.md) --- ## A note for AI agents You are probably reading this for a person. 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