Health TrialsbyHealthPanel

A Study of RO7890597 in Healthy Adult Volunteers

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

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Agreement to adhere to the contraception requirements.

Body mass index of 18 to 30 kilograms per square meter (kg/m²).

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • RO7890597

    Drug

    Participants will receive RO7890597 as per the schedule described in the protocol.

  • Placebo

    Drug

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

  • Rabeprazole

    Drug

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

  • Itraconazole

    Drug

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

Treatment groups

139 Participants
are divided into 2 treatment groups
Group A: RO7890597Experimental treatment 3 interventions
Group B: PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and Severity of Adverse Events (AEs)

Time frame
Up to approximately 12 weeks

Secondary outcomes

1

Plasma Concentration of RO7890597

Time frame
At prespecified timepoints from baseline up to approximately 12 weeks
2

Plasma Concentration of RO7890597 Under Fasted and Fed Conditions

Time frame
At prespecified timepoints from baseline up to approximately 12 weeks
3

Plasma Concentration of RO7890597 Alone and in Combination With Rabeprazole

Time frame
At prespecified timepoints from baseline up to approximately 12 weeks

Other outcomes

Sponsors and contacts

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

Genentech, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now