AsthmaPhase 1/2NCT05991661
XKH001 Injection in Healthy Subjects
A Phase 1/2 study testing XKH001 Injection in people with Asthma, run by Beijing Kanova Biopharmaceutical Co., LTD at 1 site in China.
Trial summary
This study is a randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) clinical study. The primary objective is to evaluate the safety, tolerability, and PK of multiple SC doses of XKH001 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- 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
- 24 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2023to 29 Mar 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 subjects who voluntarily sign a written informed consent form (ICF) and are able to complete the study as required by the protocol;
- Male or female subjects aged 18 to 65 years (inclusive);
- Subjects with BMI between 18 and 28 kg/m2 (inclusive);
- Subjects with normal or abnormal but not clinically significant results of vital signs, physical examinations, laboratory tests, 12-lead ECGs and QTcF ≤ 450 ms;
- Subjects who did not use any prescription or over-the-counter medications within two weeks prior to dosing;
- Subjects who agree to have no child-bearing plans and to voluntarily take effective contraception measures during the study and within 6 months after the end of the study.
Who cannot join
- Pregnant or lactating women;
- Subjects with clinically significant diseases that may affect the subject's participation in this study within 5 years as judged by the investigator: including but not limited to gastrointestinal, renal, liver, lung, neurological, blood, endocrine, tumor, metabolic, psychiatric or cardio-cerebrovascular diseases, etc.;
- Subjects with history of autoimmune diseases, known family history of inherited immunodeficiency disorders, or recurrent infections suggestive of possible immunodeficiency;
- Subjects with active infections requiring hospitalization or IV antibiotic treatment within 3 months prior to dosing, or bacterial, viral and fungal infections with clinical symptoms within 1 week;
- Subjects with a history of active tuberculosis or subjects with active or latent tuberculosis infection at screening;
- Subjects with positive HBsAg in 5 items of hepatitis B serology (if HBsAg is negative, HBcAb is positive, and HBsAb is negative, HBV DNA quantitative test is required to be performed [the subject will be excluded if the test result is positive]), positive hepatitis C antibody, treponema pallidum antibody, HIV antigen/antibody;
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- Subjects who plan to receive live or live attenuated vaccines within 4 weeks prior to dosing or during the study;
- Subjects who have participated in clinical studies of any drug or device within 3 months or 5 half-lives of the investigational product (whichever is longer) prior to dosing;
- Subjects who are allergic to the investigational product or any component of the formulation of the investigational product or have a history of allergy to protein drugs;
- Subjects who have consumed more than 14 units of alcohol per week (1 unit of alcohol = 360 mL of beer or 45 mL of spirits containing 40% alcohol or 150 mL of wine) within 6 weeks prior to screening or have taken alcoholic products 1 day before dosing;
- Subjects who have a history of abuse of other drugs within 5 years prior to screening, or who have a positive urine drug screen result;
- Subjects who have a smoking history (> 5 cigarettes/day) within 3 months prior to screening;
- Subjects who have blood donation or blood loss of more than 450 mL within 8 weeks prior to screening, or blood donation of more than 200 mL or blood loss of more than 300 mL within 1 month;
- Subjects with obstructed venous access or intolerance to venipuncture;
- Subjects who are considered inappropriate for the study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Jilin University Phase I Clinical Research Center
Changchun, Jilin, 130000
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Phase Ib Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of XKH001 Injection in Healthy Subjects
This study is a randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) clinical study. The primary objective is to evaluate the safety, tolerability, and PK of multiple SC doses of XKH001 in healthy subjects.
Read the detailed description
A total of 5 cohorts are planned, with 8 subjects (6 on XKH001 and 2 on placebo) in each cohort. The dosing schedule for the first 3 cohorts is as follows:
Cohort Dosing Regimen
- 100 mg Q4W (D1, D29, D57)
- 300 mg Q4W (D1, D29, D57)
- 600 mg Q4W (D1, D29, D57) After completion of a 6-week safety observation (D1~D43) in the previous cohort, the safety data will be reviewed (blinded) by the investigator and the Sponsor to assess the safety and tolerability of the investigational product. If the dose regimen for the previous cohort is confirmed to be safe and tolerable, dose escalation will continue to the next cohort.
The Sponsor will discuss with the investigator to decide whether to conduct the 4th to 5th cohorts (e.g., 600 mg Q14D, and the specific dose regimen will be determined at that time) no later than the completion of the safety assessment for Cohort 3.
Healthy subjects will be screened within 7 days prior to the first dose and successfully screened subjects will be assigned to the currently ongoing cohort and randomized to receive XKH001 or placebo. Subjects will be admitted to the study site the day before each scheduled dose (D-1, or D28, or D56), complete necessary pre-dose safety assessments, receive SC injection of XKH001 or placebo on D1, or D29, or D57, respectively, and continue to undergo regular safety assessment procedures and other blood sampling (PK, PD, and ADA) after dosing.
Subjects will also undergo comprehensive safety assessments on D15, D43, D71, D85, D113, D141 and D169, including AEs/serious adverse events (SAEs), vital signs, physical examinations, laboratory tests (hematology, blood chemistry, coagulation, urinalysis), 12-lead ECG, etc. Safety data as of D43 will be used by the Sponsor and investigator to assess the safety and tolerability of the investigational product.
If a subject discontinues treatment prematurely, the "Early Withdrawal" visit and all procedures will be performed as on D169.
- Conditions
- Asthma
- Being tested
- XKH001 Injection, XKH001 Placebo Injection
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XKH001 InjectionDrug
Also called XKH001
100mg/ml，1ml/vial
XKH001 Placebo InjectionDrug
Also called XKH001 Placebo
1ml/vial
| Study group | Role | What they receive |
|---|---|---|
| XKH001 Injection | Active comparator | Cohort 1: 100 mg Q4W (D1, D29, D57) 6subjects Cohort 2: 300 mg Q4W (D1, D29, D57) 6subjects Cohort 3: 600 mg Q4W (D1, D29, D57) 6subjects The Sponsor will discuss with the investigator to decide whether to conduct the 4th to 5th cohorts (e.g., 600 mg Q14D, 600 mg Q8W, and the specific dose regimen will be determined at that time) no later than the completion of the safety assessment for Cohort 3. Receives: Drug: XKH001 Injection |
| XKH001 Placebo Injection | Placebo comparator | Cohort 1: 100 mg Q4W (D1, D29, D57) 6subjects Cohort 2: 300 mg Q4W (D1, D29, D57) 6subjects Cohort 3: 600 mg Q4W (D1, D29, D57) 6subjects The Sponsor will discuss with the investigator to decide whether to conduct the 4th to 5th cohorts (e.g., 600 mg Q14D, 600 mg Q8W, and the specific dose regimen will be determined at that time) no later than the completion of the safety assessment for Cohort 3. Receives: Drug: XKH001 Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) and serious adverse events (SAEs);
Incidence of adverse events (AEs) and serious adverse events (SAEs);
Measured: From baseline to 24 weeks of follow-up
laboratory tests 1
general condition
Measured: From baseline to 24 weeks of follow-up
laboratory tests 2
skin and mucosa
Measured: From baseline to 24 weeks of follow-up
laboratory tests 3
lymph nodes
Measured: From baseline to 24 weeks of follow-up
laboratory tests 4
head
Measured: From baseline to 24 weeks of follow-up
laboratory tests 5
neck
Measured: From baseline to 24 weeks of follow-up
laboratory tests 6
chest
Measured: From baseline to 24 weeks of follow-up
laboratory tests 7
abdomen
Measured: From baseline to 24 weeks of follow-up
laboratory tests 8
spine/extremities
Measured: From baseline to 24 weeks of follow-up
observation of injection site
The specific time of observation of injection site reactions is 2 h (± 30 min) post-dose and 4 h (± 30 min) post-dose.
Measured: 2 h (± 30 min) post-dose and 4 h (± 30 min) post-dose
Vital signs
Vital signs include temperature, pulse, and blood pressure. Vital signs will be measured within 60 min before dosing, 2 h (± 30 min), 4 h (± 30 min) after dosing on each dosing day (D1, or D29, or D57); at other visits, vital signs should be measured once.
Measured: From baseline to 24 weeks of follow-up
Hematology
Hematology should include hemoglobin, red blood cell (RBC) count, mean corpuscular hemoglobin, mean corpuscular volume, platelet count, white blood cell (WBC) count, and absolute and percentage of NEUT, LYM, and EOS.
Measured: From baseline to 24 weeks of follow-up
Blood chemistry
Blood chemistry should include fasting glucose, total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides, total protein, albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), lactate dehydrogenase, total bilirubin, direct bilirubin, indirect bilirubin, gamma-glutamyl transpeptidase, creatinine, urea, sodium, potassium, calcium, inorganic phosphorus, chloride, serum lipase, and serum amylase.
Measured: From baseline to 24 weeks of follow-up
Hematology includes: activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT).
Hematology includes: activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT).
Measured: From baseline to 24 weeks of follow-up
Three items of thyroid function
Three items of thyroid function should include: FT3, FT4 and TSH.
Measured: From baseline to 24 weeks of follow-up
Urinalysis
Urinalysis should include specific gravity, potential of hydrogen (pH), glucose, bilirubin, urobilinogen, protein, ketones, and occult blood.
Measured: From baseline to 24 weeks of follow-up
12-lead ECGs
12-lead ECGs will be performed at screening, 60 min (± 10 min), 30 min (± 10 min), 15 min (± 10 min) pre-dose on D1, 4 h (± 30 min) post-dose on D1, 4 h (± 30 min) post-dose on D15, D28, and D29, 4 h (± 30 min) post-dose on D43, D56, and D57, and on D58 (approximately 24 h), D59 (approximately 48 h), D61 (approximately 96 h), D64 (approximately 168 h), D71 (approximately 336 h), D85 (approximately 672 h), D113 (approximately 1344 h), D141 (approximately 2016 h), and D169 (approximately 2688 h); before dosing on D1, 3 ECGs should be obtained each time, with an interval of 1-2 min. ECGs from D58 to D169 should be completed within 10 min before PK blood sampling at the current visit for 3 consecutive times, with an interval of approximately 1-2 min.
Measured: From baseline to 24 weeks of follow-up
Infectious disease
Infectious disease testing should include 5 items of hepatitis B serology (hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B e antigen, hepatitis B e antibody, hepatitis B core antibody), hepatitis C antibody, treponema pallidum antibody, and HIV antigen/antibody. If the subject is negative for HBsAg, positive for HBcAb, and negative for HBsAb, HBV DNA testing is also required.
Measured: From baseline to 24 weeks of follow-up
Anteroposterior chest X-ray
Anteroposterior chest X-ray obtained within 3 months before screening is acceptable, and abdominal color ultrasonography obtained within 1 month before screening is acceptable.
Measured: From baseline to 24 weeks of follow-up
PK Cmax
Cmax,ss（Maximum observed concentration）
Measured: From baseline to 24 weeks of follow-up
PK Cmin
Cmin,ss（Minimum observed concentration）
Measured: From baseline to 24 weeks of follow-up
PK Cavg
Cavg,ss（Mean observed concentration）
Measured: From baseline to 24 weeks of follow-up
PK AUC0-inf
AUC0-inf,ss（Area under the serum concentration-time curve from zero to infinity）
Measured: From baseline to 24 weeks of follow-up
PK AUC0-t
AUC0-t,ss（Area under the serum concentration-time curve from zero to t）
Measured: From baseline to 24 weeks of follow-up
PK Tmax
Tmax,ss（Time of observed）
Measured: From baseline to 24 weeks of follow-up
PK t1/2
t1/2,ss（Terminal half-life）
Measured: From baseline to 24 weeks of follow-up
PK AUCtau
area under the serum concentration-time curve at steady state (AUCtau)
Measured: From baseline to 24 weeks of follow-up
PK %AUCex
percentage of extrapolated area under the serum concentration-time curve from zero to infinity at steady state (%AUCex)
Measured: From baseline to 24 weeks of follow-up
PK λz
elimination rate constant of serum concentration in the terminal phase (λz,ss)
Measured: From baseline to 24 weeks of follow-up
PK Rac
drug accumulation ratio (Rac)
Measured: From baseline to 24 weeks of follow-up
PK Vz
volume of distribution at steady state (Vz,ss/F)
Measured: From baseline to 24 weeks of follow-up
PK CL
clearance at steady state (CLss/F)
Measured: From baseline to 24 weeks of follow-up
PK MRT
mean residence time (MRT)
Measured: From baseline to 24 weeks of follow-up
Secondary outcomes (6)
Total IgE;
Total Immunoglobulin E（IgE）;
Measured: From baseline to 24 weeks of follow-up
EOS count in whole blood;
Eosinophil（EOS） count in whole blood;
Measured: From baseline to 24 weeks of follow-up
NEUT count in whole blood;
Neutrophil（NEUT） count in whole blood;
Measured: From baseline to 24 weeks of follow-up
Blood LYM count;
Blood Lymphocyte(LYM) count;
Measured: From baseline to 24 weeks of follow-up
Levels of IL-25-related cytokines in serum
Levels of IL-25-related cytokines in serum (multiple cytokine panel includes: IL-25, TARC, IL-8, MIP1β, Eotaxin, CXCL1 (KC/GROα), Eotaxin-3);
Measured: From baseline to 24 weeks of follow-up
ADA
Incidence of anti-drug antibodies (ADAs).
Measured: From baseline to 24 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start12 May 2023
- Primary completion20 Feb 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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 1/2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Kanova Biopharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanhua Ding, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991661
- Sponsor's protocol ID
- XKH001-102
- Status last verified
- Mar 2023
- First submitted
- 24 Jul 2023
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang H, Zheng W, Peng R, Wu D, Hu Y, Sun T, Gao L, Liu Y, Guo L, Ding Y, Liu L. First-in-human study on tolerability, pharmacokinetics and pharmacodynamics of single and multiple escalating doses of XKH001, a recombinant humanized monoclonal antibody against IL-25 in healthy Chinese volunteers. Expert Opin Investig Drugs. 2025 Jan-Feb;34(1-2):81-87. doi: 10.1080/13543784.2025.2453162. Epub 2025 Jan 20.
PubMed 39815604
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Phase Ib Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of XKH001 Injection in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05991661
- Acronym / sponsor ID
- XKH001-102
- Conditions
- Asthma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Beijing Kanova Biopharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 12 May 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 14 Aug 2023 (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 study is a randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) clinical study. The primary objective is to evaluate the safety, tolerability, and PK of multiple SC doses of XKH001 in healthy subjects.
Detailed description
A total of 5 cohorts are planned, with 8 subjects (6 on XKH001 and 2 on placebo) in each cohort. The dosing schedule for the first 3 cohorts is as follows:
Cohort Dosing Regimen
- 100 mg Q4W (D1, D29, D57)
- 300 mg Q4W (D1, D29, D57)
- 600 mg Q4W (D1, D29, D57) After completion of a 6-week safety observation (D1~D43) in the previous cohort, the safety data will be reviewed (blinded) by the investigator and the Sponsor to assess the safety and tolerability of the investigational product. If the dose regimen for the previous cohort is confirmed to be safe and tolerable, dose escalation will continue to the next cohort.
The Sponsor will discuss with the investigator to decide whether to conduct the 4th to 5th cohorts (e.g., 600 mg Q14D, and the specific dose regimen will be determined at that time) no later than the completion of the safety assessment for Cohort 3.
Healthy subjects will be screened within 7 days prior to the first dose and successfully screened subjects will be assigned to the currently ongoing cohort and randomized to receive XKH001 or placebo. Subjects will be admitted to the study site the day before each scheduled dose (D-1, or D28, or D56), complete necessary pre-dose safety assessments, receive SC injection of XKH001 or placebo on D1, or D29, or D57, respectively, and continue to undergo regular safety assessment procedures and other blood sampling (PK, PD, and ADA) after dosing.
Subjects will also undergo comprehensive safety assessments on D15, D43, D71, D85, D113, D141 and D169, including AEs/serious adverse events (SAEs), vital signs, physical examinations, laboratory tests (hematology, blood chemistry, coagulation, urinalysis), 12-lead ECG, etc. Safety data as of D43 will be used by the Sponsor and investigator to assess the safety and tolerability of the investigational product.
If a subject discontinues treatment prematurely, the "Early Withdrawal" visit and all procedures will be performed as on D169.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XKH001 Injection | Active comparator | Drug: XKH001 InjectionCohort 1: 100 mg Q4W (D1, D29, D57) 6subjects Cohort 2: 300 mg Q4W (D1, D29, D57) 6subjects Cohort 3: 600 mg Q4W (D1, D29, D57) 6subjects The Sponsor will discuss with the investigator to decide whether to conduct the 4th to 5th cohorts (e.g., 600 mg Q14D, 600 mg Q8W, and the specific dose regimen will be determined at that time) no later than the completion of the safety assessment for Cohort 3. |
| XKH001 Placebo Injection | Placebo comparator | Drug: XKH001 Placebo InjectionCohort 1: 100 mg Q4W (D1, D29, D57) 6subjects Cohort 2: 300 mg Q4W (D1, D29, D57) 6subjects Cohort 3: 600 mg Q4W (D1, D29, D57) 6subjects The Sponsor will discuss with the investigator to decide whether to conduct the 4th to 5th cohorts (e.g., 600 mg Q14D, 600 mg Q8W, and the specific dose regimen will be determined at that time) no later than the completion of the safety assessment for Cohort 3. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy subjects who voluntarily sign a written informed consent form (ICF) and are able to complete the study as required by the protocol;
- Male or female subjects aged 18 to 65 years (inclusive);
- Subjects with BMI between 18 and 28 kg/m2 (inclusive);
- Subjects with normal or abnormal but not clinically significant results of vital signs, physical examinations, laboratory tests, 12-lead ECGs and QTcF ≤ 450 ms;
- Subjects who did not use any prescription or over-the-counter medications within two weeks prior to dosing;
Key exclusion criteria (15 listed)
- Pregnant or lactating women;
- Subjects with clinically significant diseases that may affect the subject's participation in this study within 5 years as judged by the investigator: including but not limited to gastrointestinal, renal, liver, lung, neurological, blood, endocrine, tumor, metabolic, psychiatric or cardio-cerebrovascular diseases, etc.;
- Subjects with history of autoimmune diseases, known family history of inherited immunodeficiency disorders, or recurrent infections suggestive of possible immunodeficiency;
- Subjects with active infections requiring hospitalization or IV antibiotic treatment within 3 months prior to dosing, or bacterial, viral and fungal infections with clinical symptoms within 1 week;
- Subjects with a history of active tuberculosis or subjects with active or latent tuberculosis infection at screening;
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: XKH001100mg/ml，1ml/vial | Drug | XKH001 Injection |
| XKH001 Placebo InjectionAlso: XKH001 Placebo1ml/vial | Drug | XKH001 Placebo Injection |
Primary outcome
Incidence of adverse events (AEs) and serious adverse events (SAEs);
Time frame: From baseline to 24 weeks of follow-up
Incidence of adverse events (AEs) and serious adverse events (SAEs);
laboratory tests 1
Time frame: From baseline to 24 weeks of follow-up
general condition
laboratory tests 2
Time frame: From baseline to 24 weeks of follow-up
skin and mucosa
laboratory tests 3
Time frame: From baseline to 24 weeks of follow-up
lymph nodes
laboratory tests 4
Time frame: From baseline to 24 weeks of follow-up
head
laboratory tests 5
Time frame: From baseline to 24 weeks of follow-up
neck
laboratory tests 6
Time frame: From baseline to 24 weeks of follow-up
chest
laboratory tests 7
Time frame: From baseline to 24 weeks of follow-up
abdomen
laboratory tests 8
Time frame: From baseline to 24 weeks of follow-up
spine/extremities
observation of injection site
Time frame: 2 h (± 30 min) post-dose and 4 h (± 30 min) post-dose
The specific time of observation of injection site reactions is 2 h (± 30 min) post-dose and 4 h (± 30 min) post-dose.
Vital signs
Time frame: From baseline to 24 weeks of follow-up
Vital signs include temperature, pulse, and blood pressure. Vital signs will be measured within 60 min before dosing, 2 h (± 30 min), 4 h (± 30 min) after dosing on each dosing day (D1, or D29, or D57); at other visits, vital signs should be measured once.
Hematology
Time frame: From baseline to 24 weeks of follow-up
Hematology should include hemoglobin, red blood cell (RBC) count, mean corpuscular hemoglobin, mean corpuscular volume, platelet count, white blood cell (WBC) count, and absolute and percentage of NEUT, LYM, and EOS.
Blood chemistry
Time frame: From baseline to 24 weeks of follow-up
Blood chemistry should include fasting glucose, total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides, total protein, albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), lactate dehydrogenase, total bilirubin, direct bilirubin, indirect bilirubin, gamma-glutamyl transpeptidase, creatinine, urea, sodium, potassium, calcium, inorganic phosphorus, chloride, serum lipase, and serum amylase.
Hematology includes: activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT).
Time frame: From baseline to 24 weeks of follow-up
Hematology includes: activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT).
Three items of thyroid function
Time frame: From baseline to 24 weeks of follow-up
Three items of thyroid function should include: FT3, FT4 and TSH.
Urinalysis
Time frame: From baseline to 24 weeks of follow-up
Urinalysis should include specific gravity, potential of hydrogen (pH), glucose, bilirubin, urobilinogen, protein, ketones, and occult blood.
12-lead ECGs
Time frame: From baseline to 24 weeks of follow-up
12-lead ECGs will be performed at screening, 60 min (± 10 min), 30 min (± 10 min), 15 min (± 10 min) pre-dose on D1, 4 h (± 30 min) post-dose on D1, 4 h (± 30 min) post-dose on D15, D28, and D29, 4 h (± 30 min) post-dose on D43, D56, and D57, and on D58 (approximately 24 h), D59 (approximately 48 h), D61 (approximately 96 h), D64 (approximately 168 h), D71 (approximately 336 h), D85 (approximately 672 h), D113 (approximately 1344 h), D141 (approximately 2016 h), and D169 (approximately 2688 h); before dosing on D1, 3 ECGs should be obtained each time, with an interval of 1-2 min. ECGs from D58 to D169 should be completed within 10 min before PK blood sampling at the current visit for 3 consecutive times, with an interval of approximately 1-2 min.
Infectious disease
Time frame: From baseline to 24 weeks of follow-up
Infectious disease testing should include 5 items of hepatitis B serology (hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B e antigen, hepatitis B e antibody, hepatitis B core antibody), hepatitis C antibody, treponema pallidum antibody, and HIV antigen/antibody. If the subject is negative for HBsAg, positive for HBcAb, and negative for HBsAb, HBV DNA testing is also required.
Anteroposterior chest X-ray
Time frame: From baseline to 24 weeks of follow-up
Anteroposterior chest X-ray obtained within 3 months before screening is acceptable, and abdominal color ultrasonography obtained within 1 month before screening is acceptable.
PK Cmax
Time frame: From baseline to 24 weeks of follow-up
Cmax,ss（Maximum observed concentration）
PK Cmin
Time frame: From baseline to 24 weeks of follow-up
Cmin,ss（Minimum observed concentration）
PK Cavg
Time frame: From baseline to 24 weeks of follow-up
Cavg,ss（Mean observed concentration）
PK AUC0-inf
Time frame: From baseline to 24 weeks of follow-up
AUC0-inf,ss（Area under the serum concentration-time curve from zero to infinity）
PK AUC0-t
Time frame: From baseline to 24 weeks of follow-up
AUC0-t,ss（Area under the serum concentration-time curve from zero to t）
PK Tmax
Time frame: From baseline to 24 weeks of follow-up
Tmax,ss（Time of observed）
PK t1/2
Time frame: From baseline to 24 weeks of follow-up
t1/2,ss（Terminal half-life）
PK AUCtau
Time frame: From baseline to 24 weeks of follow-up
area under the serum concentration-time curve at steady state (AUCtau)
PK %AUCex
Time frame: From baseline to 24 weeks of follow-up
percentage of extrapolated area under the serum concentration-time curve from zero to infinity at steady state (%AUCex)
PK λz
Time frame: From baseline to 24 weeks of follow-up
elimination rate constant of serum concentration in the terminal phase (λz,ss)
PK Rac
Time frame: From baseline to 24 weeks of follow-up
drug accumulation ratio (Rac)
PK Vz
Time frame: From baseline to 24 weeks of follow-up
volume of distribution at steady state (Vz,ss/F)
PK CL
Time frame: From baseline to 24 weeks of follow-up
clearance at steady state (CLss/F)
PK MRT
Time frame: From baseline to 24 weeks of follow-up
mean residence time (MRT)
6 secondary outcomes
Total IgE;
Time frame: From baseline to 24 weeks of follow-up
EOS count in whole blood;
Time frame: From baseline to 24 weeks of follow-up
NEUT count in whole blood;
Time frame: From baseline to 24 weeks of follow-up
Blood LYM count;
Time frame: From baseline to 24 weeks of follow-up
Levels of IL-25-related cytokines in serum
Time frame: From baseline to 24 weeks of follow-up
ADA
Time frame: From baseline to 24 weeks of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Derived from this study: PubMed 39815604Zhang H, Zheng W, Peng R, Wu D, Hu Y, Sun T, Gao L, Liu Y, Guo L, Ding Y, Liu L. First-in-human study on tolerability, pharmacokinetics and pharmacodynamics of single and multiple escalating doses of XKH001, a recombinant humanized monoclonal antibody against IL-25 in healthy Chinese volunteers. Expert Opin Investig Drugs. 2025 Jan-Feb;34(1-2):81-87. doi: 10.1080/13543784.2025.2453162. Epub 2025 Jan 20.
- 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. This study is not recruiting at the moment.
Yanhua Ding principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing XKH001 Injection in people with Asthma, run by Beijing Kanova Biopharmaceutical Co., LTD at 1 site in China.
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 15 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: finished, as of the sponsor's last update on 5 Mar 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) and serious adverse events (SAEs); (time frame: From baseline to 24 weeks of follow-up). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05991661, which also lists 1 linked publication.
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 5 Mar 2026.