Phase 1 study
Not yet recruiting Phase 1
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Q-Pharm Pty Limited (also known as Nucleus Network Brisbane) | Melbourne | Australia | Status not stated |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
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.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 11 August 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.