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A Study of RO7890597 in Healthy Adult Volunteers
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Healthy Volunteers
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Basic Details
Sponsor
Genentech, Inc.
Phase
Phase 1
Trial Identifier
NCT07797478, GA46708
Condition
Healthy 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
Study 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.
Eligibility Criteria
All
≥18 Years & ≤ 65 Years
Accepts Healthy Volunteers
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.
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com