None listed
Conditions
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.
Interventions
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 ev
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.
Sponsors
MDCECRO AUSTRALIA PTY. LTD.
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
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
Outcome results
None listed