Bridging Study of XKH001 in Healthy Adult Caucasian Participants

NCT07757659 | Not Yet Recruiting Phase 1

• 1 other identifier: XKH001-01-Id
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adult

Outcome Measures

Primary Outcomes (19)

• Primary Outcome 1

  Maximum observed serum concentration at steady state (Cmax,ss)

  Day 1, Day 29, and Day 57

• Primary Outcome 2

  Minimum observed serum concentration at steady state (Cmin,ss)

  Day 1, Day 29, and Day 57

• Primary Outcome 3

  Average serum concentration at steady state (Cavg,ss)

  Day 1, Day 29, and Day 57

• Primary Outcome 4

  Area under the serum concentration-time curve from time zero to the last quantifiable concentration at steady state (AUC0-t,ss)

  Day 1, Day 29, and Day 57

• Primary Outcome 5

  Area under the serum concentration-time curve from time zero to the theoretical infinite time at steady state (AUC0-inf,ss)

  Day 1, Day 29, and Day 57

• Primary Outcome 6

  Area under the serum concentration-time curve over one dosing interval at steady state (AUCtau)

  Day 1, Day 29, and Day 57

• Primary Outcome 7

  Time to maximum observed serum concentration at steady state (tmax,ss)

  Day 1, Day 29, and Day 57

• Primary Outcome 8

  Terminal elimination half-life at steady state (t½,ss)

  Day 1, Day 29, and Day 57

• Primary Outcome 9

  Mean residence time at steady state (MRTss)

  Day 1, Day 29, and Day 57

• Primary Outcome 10

  Terminal elimination rate constant (λz,ss)

  Day 1, Day 29, and Day 57

• Primary Outcome 11

  Percent of extrapolated area under the curve (%AUCex)

  Day 1, Day 29, and Day 57

• Primary Outcome 12

  Accumulation ratio based on Cmax and AUC (Rac)

  Day 1, Day 29, and Day 57

• Primary Outcome 13

  Apparent clearance at steady state (CLss/F)

  Day 1, Day 29, and Day 57

• Primary Outcome 14

  Apparent volume of distribution at steady state (Vz,ss/F)

  Day 1, Day 29, and Day 57

• Primary Outcome 15

  Incidence, severity, seriousness, and relationship to study treatment of treatment-emergent adverse events (TEAEs)

  first dose administration through Day 169

• Primary Outcome 16

  Incidence, severity, seriousness, and relationship to study treatment of treatment-emergent serious adverse events (SAEs)

  first dose administration through Day 169

• Primary Outcome 17

  Incidence, severity, seriousness, and relationship to study treatment of treatment-emergent adverse drug reactions (ADRs)

  first dose administration through Day 169

• Primary Outcome 18

  Incidence, severity, seriousness, and relationship to study treatment of treatment-emergent suspected unexpected serious adverse reactions (SUSARs)

  first dose administration through Day 169

• Primary Outcome 19

  Incidence and severity of local injection-site reactions following subcutaneous administration of XKH001 or placebo

  first dose administration through Day 169

Secondary Outcomes (3)

• Secondary Outcome 1

  Day 1, Day 29, and Day 57, and during follow-up visits on Day 85, Day 113, and Day 169.

• Secondary Outcome 2

  Day 1, Day 29, and Day 57, and during follow-up visits on Day 85, Day 113, and Day 169.

• Secondary Outcome 3

  Day 1, Day 29, and Day 57, and during follow-up visits on Day 85, Day 113, and Day 169.

Other Outcomes (5)

• Other Pre-specified Outcomes1

  Day 1, Day 29, and Day 57, Day 85, Day 113, Day 169.

• Other Pre-specified Outcomes2

  Day 1, Day 29, and Day 57, Day 85, Day 113, Day 169.

• Other Pre-specified Outcomes3

  Day 1, Day 29, and Day 57, Day 85, Day 113, Day 169.

Study Arms (2)

Cohort 1

ACTIVE COMPARATOR

Cohort 1 will receive 300 mg XKH001 Injection or XKH001 Placebo Injection

Drug: XKH001 Injection; Drug: XKH001 Placebo Injection

Cohort 2

ACTIVE COMPARATOR

Cohort 2 will receive 600 mg XKH001 Injection or XKH001 Placebo Injection

Drug: XKH001 Injection; Drug: XKH001 Placebo Injection

Interventions

XKH001 Injection DRUG

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.

Also known as: XKH001

Cohort 1; Cohort 2

XKH001 Placebo Injection DRUG

Placebo；

Also known as: Placebo

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy participants who voluntarily provide written informed consent and can comply with all study procedures according to the protocol.
• Male or female participants of Caucasian ethnicity(both biological parents and all four grandparents of Caucasian origin), 18-65 years of age (inclusive).
• Body mass index (BMI) between 18.0-32.0 kg/m² (inclusive).
• 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.
• No use of prescription or over-the-counter medications within 4 weeks prior to first dosing.
• 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.

You may not qualify if:

• Pregnant or breastfeeding women.
• Any clinically significant disease within 5 years that could affect participation (gastrointestinal, renal, hepatic, pulmonary, neurology, Haematology, endocrine, oncology, metabolic, psychiatric, or cerebrovascular).
• History of autoimmune disease, known hereditary immunodeficiency, or recurrent infections suggesting immunodeficiency.
• 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.
• Active or latent tuberculosis infection.
• HBsAg positive, HCV antibody positive, syphilis antibody positive, or HIV antigen/antibody positive.
• Live or attenuated vaccine within 4 weeks prior to dosing or planned during trial.
• Participation in any clinical trial within 3 months or 5 half-lives of the investigational drug (whichever is longer) prior to dosing.
• History of allergy to the investigational drug, any formulation component, or protein-based drugs.
• 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).
• Smoking history (\>5 cigarettes/day) within 3 months prior to screening.
• Blood donation or loss \>450 mL within 8 weeks, or \>200 mL blood donation or \>300 mL blood loss within 1 month.
• Unsuitable venous access or intolerance of venipuncture.
• Prior exposure to any anti-IL-25 therapeutic agent, including XKH001 or any other investigational or approved therapeutic agent targeting IL-25.
• Any other reason deemed unsuitable by the investigator.

Sponsors & Collaborators

• Zhejiang Kanova Biopharmaceutical Co., LTD: lead

Study Sites (1)

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

Melbourne, Australia

Location

Central Study Contacts

Jiangguo You

CONTACT

010-82176552; jianguo.you@kanovabiopharma.com

Yaxin Li

CONTACT

010-82176552; yaxin.li@kanovabiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 11, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)