Recruiting NCT07342114

A Dose-Escalation Study of RO7875913 in Healthy Participants

Phase I Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: RO7875913, Placebo.
Who it may be relevant to: Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 65 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: New Zealand
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

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

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

Drug RO7875913
Participants will receive RO7875913 as per the schedule described in the protocol.
Drug Placebo
Participants will receive placebo as per the schedule described in the protocol.

Percentage of Participants with Adverse Events (AEs) [Time frame: Up to approximately 3 months]

Secondary outcome measures (4)

Serum concentration of RO7875913 [Time frame: Up to Day 76]
Percentage of Participants with Anti-Drug Antibodies (ADAs) to RO7875913 at Baseline and with ADAs to RO7875913 During the Treatment Period [Time frame: Baseline, Up to Day 76]
Recommended Phase II Dose (RP2D) of RO7875913 [Time frame: Up to approximately 3 months]
Observed Value of Pharmacodynamic Markers [Time frame: Baseline, up to approximately 3 months]

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)

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

New Zealand · 1 center

NCT: NCT07342114 · GO46451