Healthy AdultPhase 1NCT07757659
Bridging Study of XKH001 in Healthy Adult Caucasian Participants
A Phase 1 study testing XKH001 Injection in people with Healthy Adult, run by Zhejiang Kanova Biopharmaceutical Co., LTD at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- XKH001 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Aug 2026to 1 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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).
- Drug abuse or illicit substance use within 5 years, or positive urine drug screen(A positive cotinine result alone is not exclusionary).
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Q-Pharm Pty Limited (also known as Nucleus Network Brisbane)
Melbourne
Jian guo You, 010-82176552, jianguo.you@kanovabiopharma.com
About this study
Official 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
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.
Read the detailed description
The study will consist of two cohorts of healthy adult Caucasian participants. Cohort 1 will receive XKH001 300 mg subcutaneously once every 4 weeks (Q4W) on Day 1, Day 29, and Day 57... Cohort 2 will receive XKH001 600 mg subcutaneously Q4W on Day 1, Day 29, and Day 57. 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 A total of 16 healthy adult Caucasian participants will be enrolled in the study, with 8 participants per cohort. Within each cohort, participants will be randomised in a 3:1 ratio (6 active drug XKH001; 2 placebo) in a double-blind manner. Randomisation will be performed using a cohort-specific block randomisation schedule to maintain allocation concealment and treatment balance within each cohort. Enrolment will not be stratified by sex; however, at least 3 female participants will be enrolled in each cohort to ensure adequate female representation and to ensure that at least 1 female participant receives the investigational drug.
- Conditions
- Healthy Adult
- Being tested
- XKH001 Injection, XKH001 Placebo Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XKH001 InjectionDrug
Also called XKH001
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 InjectionDrug
Also called Placebo
Placebo；
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | Cohort 1 will receive 300 mg XKH001 Injection or XKH001 Placebo Injection Receives: Drug: XKH001 Injection; Drug: XKH001 Placebo Injection |
| Cohort 2 | Active comparator | Cohort 2 will receive 600 mg XKH001 Injection or XKH001 Placebo Injection Receives: Drug: XKH001 Injection; Drug: XKH001 Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome 1
Maximum observed serum concentration at steady state (Cmax,ss)
Measured: Day 1, Day 29, and Day 57
Primary Outcome 2
Minimum observed serum concentration at steady state (Cmin,ss)
Measured: Day 1, Day 29, and Day 57
Primary Outcome 3
Average serum concentration at steady state (Cavg,ss)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Day 1, Day 29, and Day 57
Primary Outcome 7
Time to maximum observed serum concentration at steady state (tmax,ss)
Measured: Day 1, Day 29, and Day 57
Primary Outcome 8
Terminal elimination half-life at steady state (t½,ss)
Measured: Day 1, Day 29, and Day 57
Primary Outcome 9
Mean residence time at steady state (MRTss)
Measured: Day 1, Day 29, and Day 57
Primary Outcome 10
Terminal elimination rate constant (λz,ss)
Measured: Day 1, Day 29, and Day 57
Primary Outcome 11
Percent of extrapolated area under the curve (%AUCex)
Measured: Day 1, Day 29, and Day 57
Primary Outcome 12
Accumulation ratio based on Cmax and AUC (Rac)
Measured: Day 1, Day 29, and Day 57
Primary Outcome 13
Apparent clearance at steady state (CLss/F)
Measured: Day 1, Day 29, and Day 57
Primary Outcome 14
Apparent volume of distribution at steady state (Vz,ss/F)
Measured: Day 1, Day 29, and Day 57
Primary Outcome 15
Incidence, severity, seriousness, and relationship to study treatment of treatment-emergent adverse events (TEAEs)
Measured: first dose administration through Day 169
Primary Outcome 16
Incidence, severity, seriousness, and relationship to study treatment of treatment-emergent serious adverse events (SAEs)
Measured: first dose administration through Day 169
Primary Outcome 17
Incidence, severity, seriousness, and relationship to study treatment of treatment-emergent adverse drug reactions (ADRs)
Measured: 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)
Measured: first dose administration through Day 169
Primary Outcome 19
Incidence and severity of local injection-site reactions following subcutaneous administration of XKH001 or placebo
Measured: first dose administration through Day 169
Secondary outcomes (3)
Secondary Outcome 1
Incidence of anti-drug antibodies (ADA) to XKH001, including neutralising antibody (NAb) status for confirmed ADA-positive samples
Measured: Day 1, Day 29, and Day 57, and during follow-up visits on Day 85, Day 113, and Day 169.
Secondary Outcome 2
Prevalence of anti-drug antibodies (ADA) to XKH001, including neutralising antibody (NAb) status for confirmed ADA-positive samples
Measured: Day 1, Day 29, and Day 57, and during follow-up visits on Day 85, Day 113, and Day 169.
Secondary Outcome 3
Characterisation of anti-drug antibodies (ADA) to XKH001, including neutralising antibody (NAb) status for confirmed ADA-positive samples
Measured: Day 1, Day 29, and Day 57, and during follow-up visits on Day 85, Day 113, and Day 169.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Kanova Biopharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757659
- Sponsor's protocol ID
- XKH001-01-Id
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07757659
- Acronym / sponsor ID
- XKH001-01-Id
- Conditions
- Healthy Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Zhejiang Kanova Biopharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will consist of two cohorts of healthy adult Caucasian participants. Cohort 1 will receive XKH001 300 mg subcutaneously once every 4 weeks (Q4W) on Day 1, Day 29, and Day 57... Cohort 2 will receive XKH001 600 mg subcutaneously Q4W on Day 1, Day 29, and Day 57. 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 A total of 16 healthy adult Caucasian participants will be enrolled in the study, with 8 participants per cohort. Within each cohort, participants will be randomised in a 3:1 ratio (6 active drug XKH001; 2 placebo) in a double-blind manner. Randomisation will be performed using a cohort-specific block randomisation schedule to maintain allocation concealment and treatment balance within each cohort. Enrolment will not be stratified by sex; however, at least 3 female participants will be enrolled in each cohort to ensure adequate female representation and to ensure that at least 1 female participant receives the investigational drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Drug: XKH001 Injection, Drug: XKH001 Placebo InjectionCohort 1 will receive 300 mg XKH001 Injection or XKH001 Placebo Injection |
| Cohort 2 | Active comparator | Drug: XKH001 Injection, Drug: XKH001 Placebo InjectionCohort 2 will receive 600 mg XKH001 Injection or XKH001 Placebo Injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XKH001 InjectionAlso: XKH001XKH001, 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. | Drug | Cohort 1, Cohort 2 |
| XKH001 Placebo InjectionAlso: PlaceboPlacebo； | Drug | Cohort 1, Cohort 2 |
Primary outcome
Primary Outcome 1
Time frame: Day 1, Day 29, and Day 57
Maximum observed serum concentration at steady state (Cmax,ss)
Primary Outcome 2
Time frame: Day 1, Day 29, and Day 57
Minimum observed serum concentration at steady state (Cmin,ss)
Primary Outcome 3
Time frame: Day 1, Day 29, and Day 57
Average serum concentration at steady state (Cavg,ss)
Primary Outcome 4
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1, Day 29, and Day 57
Time to maximum observed serum concentration at steady state (tmax,ss)
Primary Outcome 8
Time frame: Day 1, Day 29, and Day 57
Terminal elimination half-life at steady state (t½,ss)
Primary Outcome 9
Time frame: Day 1, Day 29, and Day 57
Mean residence time at steady state (MRTss)
Primary Outcome 10
Time frame: Day 1, Day 29, and Day 57
Terminal elimination rate constant (λz,ss)
Primary Outcome 11
Time frame: Day 1, Day 29, and Day 57
Percent of extrapolated area under the curve (%AUCex)
Primary Outcome 12
Time frame: Day 1, Day 29, and Day 57
Accumulation ratio based on Cmax and AUC (Rac)
Primary Outcome 13
Time frame: Day 1, Day 29, and Day 57
Apparent clearance at steady state (CLss/F)
Primary Outcome 14
Time frame: Day 1, Day 29, and Day 57
Apparent volume of distribution at steady state (Vz,ss/F)
Primary Outcome 15
Time frame: first dose administration through Day 169
Incidence, severity, seriousness, and relationship to study treatment of treatment-emergent adverse events (TEAEs)
Primary Outcome 16
Time frame: first dose administration through Day 169
Incidence, severity, seriousness, and relationship to study treatment of treatment-emergent serious adverse events (SAEs)
Primary Outcome 17
Time frame: first dose administration through Day 169
Incidence, severity, seriousness, and relationship to study treatment of treatment-emergent adverse drug reactions (ADRs)
Primary Outcome 18
Time frame: 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
Time frame: first dose administration through Day 169
Incidence and severity of local injection-site reactions following subcutaneous administration of XKH001 or placebo
3 secondary outcomes
Secondary Outcome 1
Time frame: Day 1, Day 29, and Day 57, and during follow-up visits on Day 85, Day 113, and Day 169.
Secondary Outcome 2
Time frame: Day 1, Day 29, and Day 57, and during follow-up visits on Day 85, Day 113, and Day 169.
Secondary Outcome 3
Time frame: Day 1, Day 29, and Day 57, and during follow-up visits on Day 85, Day 113, and Day 169.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XKH001 Injection in people with Healthy Adult, run by Zhejiang Kanova Biopharmaceutical Co., LTD at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiangguo You (010-82176552, jianguo.you@kanovabiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome 1 (time frame: Day 1, Day 29, and Day 57). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.