A Study of RO7890597 in Healthy Adult Volunteers

NCT07797478 | Recruiting Phase 1 FDA Drug

• 1 other identifier: GA46708
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Adverse Events (AEs)

  Up to approximately 12 weeks

Secondary Outcomes (3)

• Plasma Concentration of RO7890597

  At prespecified timepoints from baseline up to approximately 12 weeks

• Plasma Concentration of RO7890597 Under Fasted and Fed Conditions

  At prespecified timepoints from baseline up to approximately 12 weeks

• Plasma Concentration of RO7890597 Alone and in Combination With Rabeprazole

  At prespecified timepoints from baseline up to approximately 12 weeks

Study Arms (2)

RO7890597

EXPERIMENTAL

Participants will receive a single or multiple doses of RO7890597 alone, or with rabeprazole or itraconazole.

Drug: RO7890597; Drug: Rabeprazole; Drug: Itraconazole

Placebo

EXPERIMENTAL

Participants will receive single or multiple doses of matching placebo.

Drug: Placebo

Interventions

RO7890597 DRUG

Participants will receive RO7890597 as per the schedule described in the protocol.

RO7890597

Placebo DRUG

Participants will receive matching placebo as per the schedule described in the protocol.

Placebo

Rabeprazole DRUG

Participants will receive rabeprazole as per the schedule described in the protocol.

RO7890597

Itraconazole DRUG

Participants will receive itraconazole as per the schedule described in the protocol.

RO7890597

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agreement to adhere to the contraception requirements.
• Body mass index of 18 to 30 kilograms per square meter (kg/m²).

You may not qualify 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.

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (1)

ICON (LPRA) - Lenexa

Lenexa, Kansas, 66219, United States

RECRUITING

Related Links

• 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.

MeSH Terms

Interventions

Rabeprazole; Itraconazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Triazoles; Azoles; Piperazines

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: GA46708 https://forpatients.roche.com/ No attachments to email below.

CONTACT

888-662-6728 (U.S. and Canada); global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: SAD and MAD stages: Double Blind Food-effect, PPI, and DDI stages: Open-label
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: September 1, 2026
• Study Start: August 28, 2026
• Primary Completion (Estimated): June 8, 2027
• Study Completion (Estimated): June 8, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)