A Dose-Escalation Study of RO7875913 in Healthy Participants

Genentech

Status and phase: Begins enrollment this month; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: RO7875913

Study type: Interventional

Funder types: Industry

Identifiers

NCT07342114

GO46451

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

RO7875913

Experimental group

Description:

Participants will receive RO7875913.

Treatment:

Drug: RO7875913

Placebo

Placebo Comparator group

Description:

Participants will receive Placebo.

Treatment:

Drug: Placebo