A Study of RO7890597 in Healthy Adult Volunteers
NCT07797478
Phase
Phase 1
Recruitment status
Recruiting
Participants
Lead sponsor
Genentech, Inc.
Start date
2026-08-28
Number of sites
- 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.
- Short title
- A Study of RO7890597 in Healthy Adult Volunteers
- 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
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-06-08
- First posted
- 2026-09-01
- Registry last updated
- 2026-10-16
- Primary completion date
- 2027-06-08
- Start date
- 2026-08-28
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Genentech, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07797478
- ClinicalTrials.gov ID
- NCT07797478
- Registry record
- Open registry record
- 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
Incidence and Severity of Adverse Events (AEs)
Timeframe: Up to approximately 12 weeks
Plasma Concentration of RO7890597
Timeframe: At prespecified timepoints from baseline up to approximately 12 weeks
Plasma Concentration of RO7890597 Under Fasted and Fed Conditions
Timeframe: At prespecified timepoints from baseline up to approximately 12 weeks
Plasma Concentration of RO7890597 Alone and in Combination With Rabeprazole
Timeframe: At prespecified timepoints from baseline up to approximately 12 weeks
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Healthy volunteers
- Yes
- Agreement to adhere to the contraception requirements.
- Body mass index of 18 to 30 kilograms per square meter (kg/m²).
- 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
- ICON (LPRA) - LenexaLenexa, United StatesRecruiting
Sources for sites
- Related resource (www.gene.com)
Sources for references