139 Participants NeededMy employer runs this trial

RO7890597 for Healthy Volunteers

RS
Fr
Overseen ByFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called RO7890597 to assess its safety and behavior in the body. Researchers are evaluating it on healthy volunteers by comparing single and multiple doses against a placebo and examining its interactions with food and other drugs. The study aims to gather data on RO7890597's safety and activity before advancing to further testing phases. Suitable candidates for this trial have a body mass index (BMI) between 18 and 30 and are willing to adhere to the study's contraception guidelines. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have taken certain investigational therapies, immunosuppressive medications, or vaccines recently. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that RO7890597 is likely to be safe for humans?

Research has shown that RO7890597 is being tested for safety in healthy volunteers. As this study is in an early phase, it primarily assesses how well participants tolerate the treatment and monitors for any side effects. Early phase trials typically involve a small number of participants and are closely monitored to ensure safety.

While no specific data from earlier studies on RO7890597 exists, early phase trials indicate that the treatment has been safe enough in lab and animal tests to proceed to human trials. If RO7890597 had been approved for another condition, it might suggest some level of safety, but this is not mentioned here.

Participants receive varying doses of RO7890597, sometimes in combination with other drugs like rabeprazole or itraconazole, to observe the body's reactions. This process helps identify any potential interactions or side effects. The trial employs both single and multiple doses, allowing researchers to thoroughly understand the treatment's safety before advancing to further studies.12345

Why do researchers think this study treatment might be promising?

RO7890597 is unique because it potentially offers a new approach by being tested in combination with rabeprazole or itraconazole, which are medications typically used for other purposes. Unlike standard treatments that might focus solely on a single pathway or mechanism, RO7890597 could provide a more comprehensive effect by interacting with these additional compounds. Researchers are excited about this treatment because its novel combination approach might enhance efficacy and offer new insights into treatment options for conditions that are currently managed with more conventional therapies.

What evidence suggests that RO7890597 could be effective?

Research on RO7890597 remains in the early stages, providing limited information on its efficacy. So far, researchers have focused on understanding the drug's pharmacokinetics and safety. Some studies have examined RO7890597's potential to reduce inflammation in blood vessels, showing promise for future treatments of related conditions. In this trial, participants will receive either RO7890597 or a placebo to further assess its safety and pharmacokinetics in healthy volunteers. However, since the drug is currently being tested in healthy volunteers, its effectiveness for specific conditions remains unknown. Further research will be necessary to understand its full potential.23678

Who Is on the Research Team?

CT

Clinical Trials

Principal Investigator

Genentech, Inc.

Are You a Good Fit for This Trial?

This trial is for healthy adults who do not have any significant medical conditions. Participants should not be taking medications or have health issues that could affect the study results.

Inclusion Criteria

Agreement to adhere to the contraception requirements
Body mass index of 18 to 30 kilograms per square meter (kg/m²)

Exclusion Criteria

I do not have a current or recent infection needing antibiotics.
Pregnant, breastfeeding, or intending to become pregnant during the study or required contraception period
I have not had major surgery in the last 28 days and do not plan to have one soon.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive single ascending doses of RO7890597 or placebo

4 weeks

Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses of RO7890597 or placebo

4 weeks

Food-effect and Proton Pump Inhibitor (PPI) Stages

Participants receive RO7890597 with food and proton pump inhibitors to assess interactions

2 weeks

Drug-Drug Interaction (DDI) Stage

Participants receive RO7890597 with other drugs to assess drug-drug interactions

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • RO7890597

Trial Overview

The study tests different doses of a new drug called RO7890597, comparing it to placebo in healthy volunteers. It also looks at how food and other drugs like rabeprazole (a stomach acid reducer) and itraconazole (an antifungal) affect RO7890597.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: RO7890597Experimental Treatment3 Interventions
Group II: PlaceboExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials
1,578
Recruited
569,000+
Ashley Magargee profile image

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway profile image

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Citations

GENENTECH, INC.

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