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NCT Number: NCT07797478

A Study of RO7890597 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.

Recruiting

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON (LPRA) - Lenexa

Lenexa, Kansas, 66219, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RO7890597

Drug

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

Placebo

Drug

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

rabeprazole

Drug

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

Itraconazole

Drug

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

Primary outcomes

  1. Incidence and Severity of Adverse Events (AEs)

    Time frame: Up to approximately 12 weeks

Secondary outcomes

  1. Plasma Concentration of RO7890597

    Time frame: At prespecified timepoints from baseline up to approximately 12 weeks

  2. Plasma Concentration of RO7890597 Under Fasted and Fed Conditions

    Time frame: At prespecified timepoints from baseline up to approximately 12 weeks

  3. Plasma Concentration of RO7890597 Alone and in Combination With Rabeprazole

    Time frame: At prespecified timepoints from baseline up to approximately 12 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

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

CONTACT

[email protected]

888-662-6728 (U.S. and Canada)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 1, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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