Clinical Trials in Australia / NCT07757659
Starting soon
Phase 1
Bridging Study of XKH001 in Healthy Adult Caucasian Participants
NCT07757659 · tracked via the Priya Life Science Australia tracker
Condition(s) studied
Healthy Adult
Investigational drug(s) / intervention(s)
XKH001 Injection →XKH001 Placebo Injection
XKH001 Injection: XKH001, developed by Zhejiang Kanova Biopharmaceutical Co., Ltd., is a recombinant anti-IL-25 humanized IgG1 monoclonal antibody (mAb) composed of two identical light chains and two identical heavy chains linked by disulfide bonds. Each light chain consists of 215 amino acids, and each heavy chain consists of 455 amino acids, for a total of 1340 amino acids.
XKH001 Placebo Injection: Placebo；
Study summary
This is a Phase Id, randomised, double-blind, placebo-controlled, multiple-dose, bridging study conducted at a single Phase I clinical research unit in Australia. The study is designed to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of XKH001 following repeated subcutaneous administration in healthy adult Caucasian participants, and to provide an ethnic-bridging pharmacokinetic comparison with the prior Phase I dataset in Chinese participants, required for XKH001's global development programme.
Eligibility
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.
Primary outcome measure(s)
- Primary Outcome 1 — Day 1, Day 29, and Day 57
Maximum observed serum concentration at steady state (Cmax,ss) - Primary Outcome 2 — Day 1, Day 29, and Day 57
Minimum observed serum concentration at steady state (Cmin,ss) - Primary Outcome 3 — Day 1, Day 29, and Day 57
Average serum concentration at steady state (Cavg,ss) - Primary Outcome 4 — Day 1, Day 29, and Day 57
Area under the serum concentration-time curve from time zero to the last quantifiable concentration at steady state (AUC0-t,ss) - Primary Outcome 5 — Day 1, Day 29, and Day 57
Area under the serum concentration-time curve from time zero to the theoretical infinite time at steady state (AUC0-inf,ss) - Primary Outcome 6 — Day 1, Day 29, and Day 57
Area under the serum concentration-time curve over one dosing interval at steady state (AUCtau) - Primary Outcome 7 — Day 1, Day 29, and Day 57
Time to maximum observed serum concentration at steady state (tmax,ss) - Primary Outcome 8 — Day 1, Day 29, and Day 57
Terminal elimination half-life at steady state (t½,ss) - Primary Outcome 9 — Day 1, Day 29, and Day 57
Mean residence time at steady state (MRTss) - Primary Outcome 10 — Day 1, Day 29, and Day 57
Terminal elimination rate constant (λz,ss) - Primary Outcome 11 — Day 1, Day 29, and Day 57
Percent of extrapolated area under the curve (%AUCex) - Primary Outcome 12 — Day 1, Day 29, and Day 57
Accumulation ratio based on Cmax and AUC (Rac) - Primary Outcome 13 — Day 1, Day 29, and Day 57
Apparent clearance at steady state (CLss/F) - Primary Outcome 14 — Day 1, Day 29, and Day 57
Apparent volume of distribution at steady state (Vz,ss/F) - Primary Outcome 15 — first dose administration through Day 169
Incidence, severity, seriousness, and relationship to study treatment of treatment-emergent adverse events (TEAEs) - Primary Outcome 16 — first dose administration through Day 169
Incidence, severity, seriousness, and relationship to study treatment of treatment-emergent serious adverse events (SAEs) - Primary Outcome 17 — first dose administration through Day 169
Incidence, severity, seriousness, and relationship to study treatment of treatment-emergent adverse drug reactions (ADRs) - Primary Outcome 18 — first dose administration through Day 169
Incidence, severity, seriousness, and relationship to study treatment of treatment-emergent suspected unexpected serious adverse reactions (SUSARs) - Primary Outcome 19 — first dose administration through Day 169
Incidence and severity of local injection-site reactions following subcutaneous administration of XKH001 or placebo
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Q-Pharm Pty Limited (also known as Nucleus Network Brisbane) | Melbourne | Australia |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07757659 on ClinicalTrials.gov ↗ ← All trials in Australia