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Can a new antibody tame the Body's allergic alarm system?

NCT ID NCT07757659

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This early-stage trial is testing an experimental drug called XKH001 in healthy Caucasian adults. The drug is an antibody designed to block a protein involved in allergic and inflammatory responses. The study aims to see how the body processes the drug, whether it is safe and well-tolerated, and how it compares to earlier results in Chinese participants. It is a small, placebo-controlled study, meaning some participants will receive the drug and others will receive an inactive injection.

What this could mean

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

Active substance
XKH001, an experimental antibody that targets a protein called IL-25, given as an injection
What this could lead to
If successful, this could support the development of XKH001 as a potential treatment for conditions involving IL-25, such as allergic or inflammatory diseases.
What could go wrong
This is a very early, small study focused on safety and drug processing, not on treating any disease. The drug may not prove effective or safe in later, larger trials.

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 2 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 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 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: 1. Healthy participants who voluntarily provide written informed consent and can comply with all study procedures according to the protocol. 2. Male or female participants of Caucasian ethnicity(both biological parents and all four grandparents of Caucasian origin), 18-65 years of age (inclusive). 3. Body mass index (BMI) between 18.0-32.0 kg/m² (inclusive). 4. Vital signs, physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG) within normal limits or considered not clinically significant by the investigator, with QTcF ≤450 ms. 5. No use of prescription or over-the-counter medications within 4 weeks prior to first dosing. 6. Participants must meet the sex- and reproductive-status-specific contraception and gamete-donation requirements specified in Appendix 2. Where contraception is required, the participant must agree to use the protocol-specified established effective contraception from the time of signing the informed consent form until 7 months after the last dose of study drug. Exclusion Criteria: 1. Pregnant or breastfeeding women. 2. Any clinically significant disease within 5 years that could affect participation (gastrointestinal, renal, hepatic, pulmonary, neurology, Haematology, endocrine, oncology, metabolic, psychiatric, or cerebrovascular). 3. History of autoimmune disease, known hereditary immunodeficiency, or recurrent infections suggesting immunodeficiency. 4. Active infection requiring hospitalisation or IV antibiotics within 3 months, or clinically symptomatic bacterial, viral, or fungal infection within 4 weeks prior to first dosing. 5. Active or latent tuberculosis infection. 6. HBsAg positive, HCV antibody positive, syphilis antibody positive, or HIV antigen/antibody positive. 7. Live or attenuated vaccine within 4 weeks prior to dosing or planned during trial. 8. Participation in any clinical trial within 3 months or 5 half-lives of the investigational drug (whichever is longer) prior to dosing. 9. History of allergy to the investigational drug, any formulation component, or protein-based drugs. 10. Alcohol consumption \>14 units/week within 6 weeks prior to screening, or alcohol-containing products within 1 day before dosing (1 unit = 8 g or 10 mL of pure alcohol). 11. Drug abuse or illicit substance use within 5 years, or positive urine drug screen(A positive cotinine result alone is not exclusionary). 12. Smoking history (\>5 cigarettes/day) within 3 months prior to screening. 13. Blood donation or loss \>450 mL within 8 weeks, or \>200 mL blood donation or \>300 mL blood loss within 1 month. 14. Unsuitable venous access or intolerance of venipuncture. 15. Prior exposure to any anti-IL-25 therapeutic agent, including XKH001 or any other investigational or approved therapeutic agent targeting IL-25. 16. Any other reason deemed unsuitable by the investigator.

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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

  • Q-Pharm Pty Limited (also known as Nucleus Network Brisbane)

    Melbourne, Australia

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