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New drug donzakimig put to the test in healthy volunteers

NCT ID NCT06716879

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-stage study tested the safety and how the body processes a single dose of donzakimig in 32 healthy Chinese and Japanese adults. Participants received either the drug or a placebo, and researchers monitored for side effects and drug levels in the blood. The goal was to gather safety information, not to treat any disease.

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

32 people

The number who actually took part.

Started

Dec 2024

Finished

Apr 2025

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 55 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 * Study participant must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF) * Study participant who is overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac assessment * Chinese study participant who is of Chinese descent as evidenced in appearance and verbal confirmation of familial heritage and is of Chinese descent with all 4 grandparents, OR Japanese study participant who is of Japanese descent as evidenced in appearance and verbal confirmation of familial heritage and is of Japanese descent with all 4 grandparents * Study participant has a body mass index within the range of 18 to 30kg/m2 (inclusive) * Study participant can be male or female Exclusion criteria * Study participant has clinically significant multiple or severe drug allergies (including to humanized monoclonal antibodyies (mAbs), intolerance to topical corticosteroids, severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis), known relevant allergy (not including mild seasonal hay fever and/or conjunctivitis or low grade food intolerances), pre-existing history of a relevant allergic condition, or a predisposition for an allergic reaction, as judged by the Investigator * Study participant has a recent history (within 6 months prior to Screening) or currently active clinically-significant bacterial, fungal, endoparasite (including the presence of ova, cysts, or parasites detected in stool sample provided at Screening), or viral (including hospitalization for coronavirus disease 2019 \[COVID-19\]) infection, as judged by the Investigator * Study participant has a history of inflammatory bowel disease (eg, Crohn's disease or ulcerative colitis) * Study participant has a history of diabetes * Study participant has received any vaccination within 8 weeks for live vaccines (including attenuated) and 4 weeks for nonlive vaccines prior to the Baseline Visit or is anticipated to do so within 60 days after the dose of IMP * Study participant has received Bacillus Calmette-Guerin vaccinations within 1 year prior to the Baseline Visit or will receive them within 90 days after the dose of IMP * Study participant has participated in another study of an IMP or has received any biologic agent within the 30 days prior to Screening (or 5 half-lives, whichever is longer) * Study participant has had a positive human immunodeficiency virus (HIV) antibody test * Study participant has the presence of either hepatitis B core antibody or hepatitis B surface antigen at Screening or within 3 months prior to dosing * Study participant has a positive hepatitis C antibody test result at Screening or within 3 months prior to Screening. * Study participant has a positive hepatitis C ribonucleic acid (RNA) test result at Screening or within 3 months prior to Screening

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As listed by the trial registrant

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

Contacts and locations

Locations

  • UP0142 1

    Anaheim, California, 92801, United States

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