A Dose-Escalation Study of RO7875913 in Healthy Participants

Healthy Volunteers

For Medical Professional
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Basic Details

Sponsor Genentech, Inc.

Phase Phase 1

Trial Identifier NCT07342114, GO46451

Condition Healthy Volunteers

Official Title A Phase I Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of RO7875913 in Healthy Volunteers

Study Summary

The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of RO7875913 in healthy participants.

Eligibility Criteria

Gender

All

Age

≥18 Years & ≤ 65 Years

Healthy Volunteers

Accepts Healthy Volunteers

Inclusion Criteria

Agreement to adhere to the contraception requirements
Body weight > 40 kilogram (kg) with a body mass index of 18-30 kg per meter square (kg/m^2)

Exclusion Criteria

Positive test result for hepatitis B surface antigen, hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibody screen
History of any malignancy
Major surgical procedure within 28 days prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
History or clinical manifestations of significant metabolic, hepatic, renal, pulmonary, cardiovascular, hematologic, gastrointestinal, urologic, neurologic, or psychiatric disorders
Known allergy or hypersensitivity to any component of the RO7875913 formulation
Treatment with investigational biologic therapy (or blinded comparator) within 90 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug
Treatment with investigational non-biologic therapy (or blinded comparator) within 28 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug
Treatment with any immunosuppressive medication within 28 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug

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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What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

For the latest version of this information please go to www.forpatients.roche.com

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A Dose-Escalation Study of RO7875913 in Healthy Participants

Basic Details

Study Summary

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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A Dose-Escalation Study of RO7875913 in Healthy Participants

For the latest version of this information please go to www.forpatients.roche.com