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New drug RO7806881 begins first human safety tests

NCT ID NCT07271693

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 4 times

Summary

This early-stage study is testing a new drug called RO7806881 in healthy volunteers to see if it is safe and how the body processes it. About 128 healthy adults will receive either the drug or a placebo. The main goal is to check for side effects and measure drug levels in the blood.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 128 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants must be males or females who are overtly healthy as determined by medical evaluation * Participants must have body weight (BW) ≥ 40 kilograms (kg) (not applicable to Cohort A9) and body mass index (BMI) within the range 18-32 kilograms per square meter (kg/m\^2) (inclusive) Inclusion Criteria Specific to Cohort A9 (East Asian Cohort): * Must be of ethnic Chinese, Korean, or Japanese origin * Must have a BW \>35 kg and BMI within the range 18-32 kg/m2 (inclusive) Exclusion Criteria: * Pregnancy, breastfeeding, or intention to become pregnant during the study or within 6 months after the final dose of study treatment * History of any clinically significant autoimmune, gastrointestinal, renal, hepatic, pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, or allergic disease; metabolic disorder; cancer or cirrhosis * Latent tuberculosis (TB) or potentially active TB * Any major illness within 1 month before the screening examination or any febrile illness within 1 week prior to the screening visit and up to first dose administration * Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study * History of hypersensitivity to biologic agents or any of the excipients in the formulation, or other allergy that contraindicates participation in the study * Live vaccines within 1 month of the first screening visit or during the screening period * Non-live vaccines within 2 weeks prior to dosing * Previous exposure to RO7806881 * Positive hepatitis C virus (HCV) antibody test result * Positive test results for hepatitis B infection * Positive human immunodeficiency virus (HIV) antibody test result * Positive test result consistent with cytomegalovirus (CMV) or Epstein-Barr virus (EBV)

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • New Zealand Clinical Research - Christchurch

    RECRUITING

    Christchurch, 8011, New Zealand

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