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New drug RO7875913 tested in healthy volunteers for first time

NCT ID NCT07342114

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 11, 2026 · Updated 3 times

Summary

This early-stage trial is testing a new drug called RO7875913 in 40 healthy volunteers to see if it is safe and how the body processes it. Participants will receive either the drug or a placebo. The study aims to find the right dose for future trials, but offers no direct treatment benefit to participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RO7875913

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 240 people

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

Started

Mar 2026

Expected to finish

Jun 2030

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 65 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: General: * Agreement to adhere to the contraception requirements Part A: * Body weight \> 40 kilogram (kg) with a body mass index of 18-30 kg per meter square (kg/m\^2) Part B: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy of at least 12 weeks * Agreement to provide bone marrow biopsy and aspirate samples Exclusion Criteria: General: * Treatment with any vaccine within 4 weeks prior to initiation of study drug, or vaccination scheduled to occur during the study * History or current cardiovascular or pulmonary disease that may limit the ability to respond to systemic infusion/injection reactions * 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 Part A: * 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 * Clinically apparent or familial history of autoimmune disease Part B: * Treatment with any systemic chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose of study treatment * Treatment with any immunosuppressive medication within 2 weeks prior to first dose of study treatment * Absolute plasma cell count exceeding 500/mL or 5% of the peripheral blood white cells

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • New Zealand Clinical Research - Christchurch

    Christchurch, Canterbury, 8011, New Zealand

More trials for these conditions

Other studies related to the condition(s) this trial covers.