Healthy VolunteersPhase 1NCT07797478
A Study of RO7890597 in Healthy Adult Volunteers
A Phase 1 study testing RO7890597, Rabeprazole and Itraconazole in people with Healthy Volunteers, run by Genentech, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- RO7890597, Rabeprazole and Itraconazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2026to 8 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Agreement to adhere to the contraception requirements.
- Body mass index of 18 to 30 kilograms per square meter (kg/m²).
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
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 contact
United States1 site, 1 recruiting
- Recruiting
ICON (LPRA) - Lenexa
Lenexa, Kansas, 66219
About this study
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
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.
- Conditions
- Healthy Volunteers
- Being tested
- RO7890597, Placebo, Rabeprazole, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7890597Drug
Participants will receive RO7890597 as per the schedule described in the protocol.
PlaceboDrug
Participants will receive matching placebo as per the schedule described in the protocol.
RabeprazoleDrug
Participants will receive rabeprazole as per the schedule described in the protocol.
ItraconazoleDrug
Participants will receive itraconazole as per the schedule described in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| RO7890597 | Experimental | Participants will receive a single or multiple doses of RO7890597 alone, or with rabeprazole or itraconazole. Receives: Drug: RO7890597; Drug: Rabeprazole; Drug: Itraconazole |
| Placebo | Experimental | Participants will receive single or multiple doses of matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse Events (AEs)
Measured: Up to approximately 12 weeks
Secondary outcomes (3)
Plasma Concentration of RO7890597
Measured: At prespecified timepoints from baseline up to approximately 12 weeks
Plasma Concentration of RO7890597 Under Fasted and Fed Conditions
Measured: At prespecified timepoints from baseline up to approximately 12 weeks
Plasma Concentration of RO7890597 Alone and in Combination With Rabeprazole
Measured: At prespecified timepoints from baseline up to approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start28 Aug 2026
- Primary completion8 Jun 2027 (estimated)
- Study completion8 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797478
- Sponsor's protocol ID
- GA46708
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07797478
- Acronym / sponsor ID
- GA46708
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2026 (actual)
- Primary completion
- 8 Jun 2027 (estimated)
- Study completion
- 8 Jun 2027 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RO7890597 | Experimental | Drug: RO7890597, Drug: Rabeprazole, Drug: ItraconazoleParticipants will receive a single or multiple doses of RO7890597 alone, or with rabeprazole or itraconazole. |
| Placebo | Experimental | Drug: PlaceboParticipants will receive single or multiple doses of matching placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Agreement to adhere to the contraception requirements.
- Body mass index of 18 to 30 kilograms per square meter (kg/m²).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO7890597Participants will receive RO7890597 as per the schedule described in the protocol. | Drug | RO7890597 |
| PlaceboParticipants will receive matching placebo as per the schedule described in the protocol. | Drug | Placebo |
| RabeprazoleParticipants will receive rabeprazole as per the schedule described in the protocol. | Drug | RO7890597 |
| ItraconazoleParticipants will receive itraconazole as per the schedule described in the protocol. | Drug | RO7890597 |
Primary outcome
Incidence and Severity of Adverse Events (AEs)
Time frame: Up to approximately 12 weeks
3 secondary outcomes
Plasma Concentration of RO7890597
Time frame: At prespecified timepoints from baseline up to approximately 12 weeks
Plasma Concentration of RO7890597 Under Fasted and Fed Conditions
Time frame: At prespecified timepoints from baseline up to approximately 12 weeks
Plasma Concentration of RO7890597 Alone and in Combination With Rabeprazole
Time frame: At prespecified timepoints from baseline up to approximately 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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 contact
Clinical Trials study director
Genentech, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RO7890597, Rabeprazole and Itraconazole in people with Healthy Volunteers, run by Genentech, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number: GA46708 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. and Canada), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Adverse Events (AEs) (time frame: Up to approximately 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.