ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626000935336

Ethics application status

Approved

Date submitted

14/07/2026

Date registered

29/07/2026

Date last updated

25/09/2026

Date data sharing statement initially provided

29/07/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

A Phase Id, Randomised, Double-Blind, Placebo-Controlled, Multiple-Dose Bridging Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of XKH001 in Healthy Adult Caucasian Participants

Scientific title

Additional trial identifiers [1]

XKH001-01-Id

Universal Trial Number (UTN)

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

type 2 inflammatory diseases

Condition category

Condition code

Inflammatory and Immune System

Other inflammatory or immune system disorders

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

XKH001 Injection (recombinant anti-IL-25 humanised monoclonal antibody solution for subcutaneous injection, 100 mg/mL) will be administered in two sequential cohorts. Cohort 1 receives XKH001 300 mg subcutaneously on Day 1, Day 29 and Day 57, delivered as 3 mL total volume across 2 injection sites (1.5 mL/site). Cohort 2 receives XKH001 600 mg subcutaneously on Day 1, Day 29 and Day 57, delivered as 6 mL total volume across 4 injection sites (1.5 mL/site). Participants are dosed approximately every 4 weeks (Q4W).

Dosing will be initiated sequentially, with Cohort 1 (300 mg) dosed first, followed by Cohort 2 (600 mg). Dosing in Cohort 2 will not commence earlier than 21 days after the first participant in Cohort 1 receives the first dose and may proceed only following joint review of the available Cohort 1 safety data and unanimous agreement by the Sponsor’s medical representative, the Medical Monitor, and the Principal Investigator.

The investigational product will be administered subcutaneously by appropriately trained and delegated study-site clinical staff at the Phase I unit, under the responsibility of the Principal Investigator. Participants will not self-administer the intervention.

As dosing is administered by study-site staff during inpatient stays, participant adherence to dosing is monitored by direct observation of administration. Dose administration will be documented in the participant’s source records, including date, time, dose, injection sites and any missed, delayed or incomplete dose. Investigational product accountability records will also be maintained by the study site. Any missed or delayed dose will be recorded and managed in accordance with the protocol.

Intervention code [1]

Treatment: Drugs

Description of the comparator or control

Matching placebo: sterile excipient vehicle without active ingredient, supplied in identically labelled vials with the same volume/appearance as XKH001. Placebo is administered

Control group

Placebo

Outcomes

Primary outcome [1]

Pharmacokinetic profile of XKH001 after repeated subcutaneous administration: Cmax,ss, Cmin,ss, Cavg,ss, AUC0-t,ss, AUC0-inf,ss, AUCtau, tmax,ss, t1/2,ss, MRTss, lambda z,ss, %AUCex, accumulation ratio based on Cmax and AUC, CLss/F and Vz,ss/F.

Timepoint [1]

D1_0h (within 60 min before first dose), D3 (48h±2h), D5 (96h±2h), D7 (~144h), D8 (~168h), D9 (~192h), D15 (~336h), D22 (~504h), D29_0h (within 60 min before second dose), D57_0h (within 60 min before last dose), D59 (48h±2h), D61 (96h±2h), D63 (~144h), D64 (~168h), D65 (~192h), D71 (~336h), D78 (~504h), D85 (~672h), D113 (~1344h), D141 (~2016h), D169 (~2688h). Total: 21 timepoints.

Primary outcome [2]

Safety and tolerability of XKH001 compared with placebo, assessed as a composite primary outcome.

Assessment method [2]

Safety and tolerability will be assessed as a composite primary outcome by reviewing all medical problems, symptoms or abnormal findings that occur during the study, whether or not they are considered related to the study treatment. These may include, for example, injection-site reactions such as pain, redness, swelling, itching or bruising; allergic or hypersensitivity reactions such as rash, hives, swelling, wheezing, shortness of breath or anaphylaxis; infections such as fever, sore throat or respiratory infection; changes in blood lipids; changes in liver blood tests; and abnormal platelet counts. Each event will be assessed by the study doctor for seriousness, severity, duration, outcome and possible relationship to the study treatment. Safety assessments will include clinical laboratory blood and urine tests, physical examinations, review of symptoms and concomitant medicines, injection-site assessments, vital signs and 12-lead electrocardiograms. Laboratory tests will include haematology, blood chemistry including liver function tests and lipid levels, urinalysis and pregnancy testing where applicable. Vital signs will include blood pressure, heart rate or pulse rate, respiratory rate and body temperature. Blood pressure will be measured using calibrated blood pressure monitoring equipment used at the study site. Heart rate or pulse rate, respiratory rate and body temperature will be measured using calibrated clinical equipment according to the study site’s standard procedures. The 12-lead electrocardiogram will assess heart rhythm, heart rate, PR interval, QRS duration, QT interval and corrected QT interval, and will be reviewed for clinically significant abnormalities. Other clinically relevant safety assessments will include review of injection sites, review of any new symptoms or illnesses, review of any medicines taken during the study, and assessment of whether any abnormal findings require follow-up, treatment, interruption of dosing or withdrawal from the study.

Timepoint [2]

Adverse events and other medical problems: monitored continuously from the time of informed consent at Screening through Day 169/Early Exit, including all scheduled visits. Concomitant medicines: reviewed from Screening through Day 169/Early Exit. Injection-site reactions: assessed at 2 hours and 4 hours after dosing on Day 1, Day 29 and Day 57. Vital signs: assessed at Screening, Day -1, Day 1, Day 3, Day 5, Day 9, Day 15, Day 28, Day 29, Day 43, Day 56, Day 57, Day 59, Day 61, Day 64, Day 71, Day 85, Day 113, Day 141 and Day 169/Early Exit. On dosing days, vital signs are assessed before dosing and at 2 hours and 4 hours after dosing. 12-lead electrocardiograms: assessed at Screening, Day 1, Day 15, Day 28, Day 29, Day 43, Day 56, Day 57, Day 71, Day 85, Day 113, Day 141 and Day 169/Early Exit. Physical examinations: assessed at Screening, Day -1, Day 15, Day 28, Day 43, Day 56, Day 71, Day 85, Day 113, Day 141 and Day 169/Early Exit. Haematology: assessed at Screening, Day -1, Day 1, Day 5, Day 15, Day 28, Day 29, Day 43, Day 56, Day 57, Day 59, Day 64, Day 71, Day 85, Day 113, Day 141 and Day 169/Early Exit. Biochemistry, coagulation and urinalysis: assessed at Screening, Day -1, Day 5, Day 15, Day 28, Day 43, Day 56, Day 71, Day 85, Day 113, Day 141 and Day 169/Early Exit. Pregnancy testing, where applicable: serum pregnancy testing at Screening and Day 169/Early Exit; urine pregnancy testing on Day -1, Day 28 and Day 56.

Secondary outcome [1]

Immunogenicity of XKH001

Timepoint [1]

Day 1, Day 29, Day 57, Day 85, Day 113 and Day 169 post first dose

Secondary outcome [2]

Exploratory pharmacodynamic biomarkers associated with type 2 inflammation, including total Immunoglobulin E and blood eosinophil, neutrophil, lymphocyte and monocyte counts.

Timepoint [2]

Total Immunoglobulin E: blood samples will be collected on Day 1 before the first dose, Day 3, Day 8, Day 15, Day 29 before the second dose, Day 57 before the third dose, Day 59, Day 64, Day 71 and Day 85. Changes from baseline will be assessed using the Day 1 pre-dose value as baseline. Blood eosinophil, neutrophil, lymphocyte and monocyte counts: assessed as part of haematology testing at Screening, Day -1, Day 1, Day 5, Day 15, Day 28, Day 29, Day 43, Day 56, Day 57, Day 59, Day 64, Day 71, Day 85, Day 113, Day 141 and Day 169/Early Exit. Changes from baseline will be assessed using the relevant pre-dose baseline value.

Eligibility

Key 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 less than or equal to 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.

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Healthy volunteers

Yes

Key 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

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation concealed using a central randomisation list generated by an independent statistician and implemented via an Interactive Web Response System (IWRS).

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Cohort-specific block randomisation schedule generated using validated statistical software by the study biostatistician/independent statistician before cohort initiation. Randomisation ratio is 3:1 active:placebo within each cohort. No stratification by sex.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Other

Other design features

Randomised, double-blind, placebo-controlled, multiple-dose, two-cohort bridging study

Phase

Phase 1

Type of endpoint/s

Pharmacokinetics

Statistical methods / analysis

This Phase Id PK bridging study is designed to descriptively characterise PK, safety, tolerability and immunogenicity without formal hypothesis testing. Sixteen participants (8 per cohort; 6 active and 2 placebo per cohort) were selected under the ICH E5 (R1) framework to achieve approximately 30%-35% 90% CI precision half-width around the geometric mean estimate, assuming 25%-30% inter-individual coefficient of variation. Analyses will use ITT, Safety Set, PK Analysis Set, Per-Protocol Set, Pharmacodynamic Set and Immunogenicity Set. Ethnic bridging comparability will be evaluated using geometric mean ratios and two-sided 90% confidence intervals for primary steady-state exposure parameters versus reference Chinese data. Continuous and categorical data, TEAEs, injection-site reactions, ADA and biomarker data will be summarised descriptively.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

28/09/2026

Actual

Date of last participant enrolment

Anticipated

9/11/2026

Actual

Date of last data collection

Anticipated

4/06/2027

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

MDCECRO AUSTRALIA PTY. LTD.

Address [1]

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Zhejiang Kanova Biopharmaceutical Co., Ltd.

Address [2]

Country [2]

China

Primary sponsor type

Commercial sector/Industry

Name

MDCECRO AUSTRALIA PTY. LTD.

Address

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Zhejiang Kanova Biopharmaceutical Co., Ltd.

Address [1]

Country [1]

China

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry Human Research Ethics Committee A

Ethics committee address [1]

https://bellberry.com.au/

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/07/2026

Approval date [1]

10/08/2026

Ethics approval number [1]

Summary

Brief summary

This study will evaluate XKH001, a recombinant anti-IL-25 humanised monoclonal antibody given as subcutaneous injections, in healthy adult Caucasian volunteers. The main purpose is to describe the pharmacokinetics, safety and tolerability of repeated XKH001 doses and to compare drug exposure with existing Chinese clinical data to support ethnic bridging. Sixteen participants will be enrolled into two sequential dose cohorts. Participants will receive either XKH001 300 mg or 600 mg, or matching placebo, on Day 1, Day 29 and Day 57, with follow-up to Day 169. The study will also evaluate immunogenicity and exploratory laboratory biomarkers related to type 2 inflammation.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Emma Trowbridge

Address

Q-Pharm Pty Ltd. Level 5, 300C Herston Road, Herston, Queensland 4006

Country

Australia

Phone

+61 7 3707 2720

Fax

[email protected]

Contact person for public queries

Name

Nucleus Network Brisbane

Address

Q-Pharm Pty Ltd. Level 5, 300C Herston Road, Herston, QLD 4006

Country

Australia

Phone

+61 1800 243 733

Fax

[email protected]

Contact person for scientific queries

Name

William Si

Address

MDCECRO AUSTRALIA PTY. LTD. 12 Park Street, Hyde Park, SA, 5061 Australia

Country

Australia

Phone

+86 15800861950

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

Type	Citation	Link	Email	Other Details	Attachment
Study protocol					XKH001_Clinical Study Protocol_V1.1_20260701 Clean.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically