Health TrialsbyHealthPanel

A Dose-Escalation Study of RO7875913 in Healthy Participants

ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGenentech, Inc.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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/m²)

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • RO7875913

    Drug

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

  • Placebo

    Drug

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: RO7875913Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants with Adverse Events (AEs)

Time frame
Up to approximately 3 months

Secondary outcomes

1

Serum concentration of RO7875913

Time frame
Up to Day 76
2

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
3

Recommended Phase II Dose (RP2D) of RO7875913

Time frame
Up to approximately 3 months
4

Observed Value of Pharmacodynamic Markers

Time frame
Baseline, up to approximately 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Genentech, Inc.

Lead sponsor

Source ClinicalTrials.gov
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