Recruiting
Phase 1

RO7890597

Sponsor:

Genentech, Inc.

Code:

NCT07797478

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

RO7890597

Placebo

Rabeprazole

Itraconazole

Study Details

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

Study ID

NCT07797478

Start date

Aug 28, 2026

Status verified date

Aug, 2026

Completion date

Jun 8, 2027

Anticipated

Primary completion date

Jun 8, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

139 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: RO7890597

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

experimental: Placebo

Participants will receive single or multiple doses of matching placebo.

Interventions

RO7890597

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

Placebo

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

Rabeprazole

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

Itraconazole

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

Primary outcome measure

  • Incidence and Severity of Adverse Events (AEs) [ Time Frame: Up to approximately 12 weeks ]

Central Contacts and Locations

Central contacts

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

Locations

ICON (LPRA) - Lenexa

Recruiting

Lenexa, Kansas, United States, 66219

More Information

Sponsor

Genentech, Inc.

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Genentech, Inc. on 2026-09-01.