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Asthma PatientsPhase 1NCT07070297

A Single-Arm Phase Ic Clinical Study of XKH001 Injection in Patients With Allergic Asthma After Multiple Doses

A Phase 1 study testing XKH001 Injection in people with Asthma Patients, run by Zhejiang Kanova Biopharmaceutical Co., LTD at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a single-arm, open-label clinical study. A total of 12 patients with allergic asthma are planned to be enrolled to receive XKH001 600 mg Q4W administration for the assessment of the safety, immunogenicity, PK, and PD characteristics of multiple doses. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Asthma Patients
What is being tested?
XKH001 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
26 Dec 2023to 20 Dec 2024
Phase
Phase 1
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be eligible to participate in the study, a subject must meet all of the following criteria:
  • 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), with a body mass index (BMI) between 18 and 30 kg/m2 (inclusive);
  • Subjects diagnosed with asthma according to the Guidelines for the Prevention and Treatment of Bronchial Asthma (China) 2020 with an asthma course (since the first incidence) of at least 6 months and meet the following requirements at the same time:
  • Subjects with a positive reaction to at least 1 type of aeroallergen (such as dust mites, pollen, mold, or animal hair) in the skin prick test or allergen-specific IgE testing record before screening or during screening; Subjects with the upper limit of normal (ULN) at the site ≤ total serum IgE ≤ 1000 IU/mL at screening; Subjects with the bronchial provocation test FEV1 PD20 Mch ≤ 1.075 mg; Subjects with FEV1 ≥ 70% of the predicted value at screening;
  • Subjects with occasional asthma symptoms (≤ 2 times/week), treated only with ICS-LABA inhalation (Symbicort®, budesonide and formoterol fumarate powder for inhalation, 1 inhalation per dose) as needed. The subject does not need to use other asthma medications on a daily basis, and other asthma medications have been discontinued before screening:
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  • Inhaled and nasal corticosteroids should be discontinued for 4 weeks; Leukotriene receptor antagonists should be discontinued for 2 weeks; Long-acting β-receptor agonists should be discontinued for 2 weeks; Anticholinergic drugs should be discontinued for 2 weeks; Antihistamines should be discontinued for 2 weeks; Theophylline drugs should be discontinued for 1 week.
  • Subjects with normal laboratory test and 12-lead ECG results or with abnormalities determined by the investigator not to be clinically significant at screening;
  • Women of childbearing potential must have a negative pregnancy test result and not be in the lactation period at screening; regardless of sex, all participants must agree to have no plans for reproduction during the study and within 6 months after the study, voluntarily adopt effective contraception measures, and have no plans for sperm/egg donation.

Who cannot join

  • Subjects who meet any of the following criteria must be excluded from this study:
  • Subjects who are current smokers or with a smoking history of > 10 pack-years. Subjects who have quit smoking need to have quit smoking for at least 12 months before enrollment;
  • Subjects with hospitalization or emergency visits due to respiratory system and/or asthma-related conditions within 6 months before screening;
  • Subjects with worsening or exacerbation of asthma, or the use of systemic glucocorticoid therapy within 6 weeks before or during screening;
  • Subjects with a history of alcoholism or drug abuse;
  • 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;
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  • Subjects with elevated total IgE due to reasons other than allergens (e.g. parasitic infections and hematological disorders);
  • Subjects who have undergone allergen-specific immunotherapy or used immunosuppressants within 3 months before screening;
  • Subjects who have used biologics (such as monoclonal antibodies), including investigational biologics, within 6 months before screening;
  • Subjects who have received any anti-IgE antibody treatment or bronchial thermoplasty within 12 months before screening;
  • Subjects who have received live (attenuated) viral/bacterial vaccines or intravenous (IV) immunoglobulins (IgG) within 4 weeks before screening;
  • Subjects with respiratory system infection or have received a major surgery within 8 weeks before screening;
  • Subjects with a combination of other lung diseases such as COPD, bronchiectasis, or lung fibrosis;
  • Subjects with a history of contraindications to choline, such as myocardial infarction or stroke within the past 3 months, known heart disease, uncontrolled hypertension, aortic or brain aneurysm;
  • Subjects with neoplasm malignant within 5 years before screening or current neoplasm malignant;
  • Subjects with a history of autoimmune diseases, known family history of inherited immunodeficiency disorders, or recurrent infections suggestive of possible immunodeficiency;
  • Subjects who had or currently have active tuberculosis, or active infection requiring hospitalization or IV antibiotic treatment within 3 months before 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]), hepatitis C antibody, treponema pallidum antibody, and HIV antigen/antibody;
  • Subjects who have participated in other investigational drug clinical studies within 30 days or 5 half-lives of the study drug (whichever is longer). If a subject has received an investigational drug of a biological product, e.g., a monoclonal antibody, the subject is required to have received the biological product at least 6 months before the screening visit;
  • Subjects with severe, progressive, or uncontrolled diseases such as liver, kidney, gastrointestinal, cardiovascular, hematopoietic, genitourinary, endocrine, nervous, immune system disorders, and other conditions that investigators consider unsuitable for inclusion in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

Other trials in China

About this study

Official title: A Single-Arm Study to Evaluate the Effect on Airway Hyperresponsiveness, Safety, Immunogenicity, Pharmacokinetics, and Pharmacodynamics Characteristics of XKH001 Injection in Patients With Allergic Asthma

This study is a single-arm, open-label clinical study. A total of 12 patients with allergic asthma are planned to be enrolled to receive XKH001 600 mg Q4W administration for the assessment of the safety, immunogenicity, PK, and PD characteristics of multiple doses.

Read the detailed description

This study is a single-arm, open-label clinical study. A total of 12 patients with allergic asthma are planned to be enrolled to receive XKH001 600 mg Q4W administration for the assessment of the safety, immunogenicity, PK, and PD characteristics of multiple doses.

The screening period will not be more than 28 days (i.e., 4 weeks). The treatment period will be 12 weeks, and the follow-up period will be 12 weeks.

All recruited patients with allergic asthma will undergo various screening procedures within 28 days prior to the first dose, and those who pass the screening will be sequentially enrolled.

Patients who are enrolled in the study will be admitted to the study site on the day before each scheduled dose (D-1, D28, and D56) to complete the necessary pre-dose safety assessments and receive XKH001 subcutaneous (SC) injections on D1, D29, and D57.

The patient will undergo regular safety assessment procedures (AE/SAE, vital signs, physical examination, laboratory tests, 12-lead electrocardiogram (ECG), etc.), FeNO, pulmonary function tests (FEV1 PD20 Mch), sputum induction, and other blood sample collections (PK, PD, and ADA) during the treatment period (D1-D85) and the subsequent 12-week follow-up period (~D169).

Visits and procedures at screening, treatment, and follow-up are detailed in the Schedule of Assessment.

If a subject discontinues treatment prematurely, the "Early Withdrawal" visit and all procedures will be performed, the same as D169.

If asthmatic patients test positive for seasonal allergens (such as pollen), they should avoid the allergy season when enrolling in the study.

Conditions
Asthma Patients
Being tested
XKH001 Injection
Keywords
Asthma
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

    Dosage: 600 mg Q4W (D1, D29 and D57) Method of administration: the drug will be administered by SC injection in an area 3 cm away from and within 5 cm around the umbilicus of the abdomen. Sites with skin damage, inflammation, ulceration, rash and scar should be avoided. Subjects should be closely observed for reactions within 4 h after dosing.

Study groups in NCT07070297
Study groupRoleWhat they receive
ExperimentExperimentalPatients who are enrolled in the study will be admitted to the study site on the day before each scheduled dose (D-1, D28, and D56) to complete the necessary pre-dose safety assessments and receive XKH001 subcutaneous (SC) injections on D1, D29, and D57.
Receives: Drug: XKH001 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the effect on airway hyperresponsiveness and safety of multiple doses of XKH001 injection in patients with allergic asthma.

    Changes from baseline in FEV1 PD20 Mch after treatment

    Measured: Day43, Day85

  2. To evaluate the effect on airway hyperresponsiveness and safety of multiple doses of XKH001 injection in patients with allergic asthma.1

    Incidence of AEs/SAEs

    Measured: Day169

  3. To evaluate the effect on airway hyperresponsiveness and safety of multiple doses of XKH001 injection in patients with allergic asthma.2

    Severity of AEs/SAEs

    Measured: Day169

Secondary outcomes (32)

  1. To evaluate the immunogenicity, PK characteristics, and PD characteristics of multiple doses of XKH001 injection in patients with allergic asthma.1

    Incidence of ADAs and NAb [detect NAb when ADA positive];

    Measured: Day169

  2. To evaluate the immunogenicity, PK characteristics, and PD characteristics of multiple doses of XKH001 injection in patients with allergic asthma.2

    FeNO (exhaled nitric oxide concentration);

    Measured: Day169

  3. To evaluate the immunogenicity, PK characteristics, and PD characteristics of multiple doses of XKH001 injection in patients with allergic asthma.3

    Total IgE;

    Measured: Day169

  4. To evaluate the immunogenicity, PK characteristics, and PD characteristics of multiple doses of XKH001 injection in patients with allergic asthma.4

    Levels of IL-25-related cytokines in sputum supernatants (same as serum).

    Measured: Day169

  5. To evaluate the effect on airway hyperresponsiveness and safety of multiple doses of XKH001 injection in patients with allergic asthma.6

    Cmax,ss,

    Measured: Day169

  6. To evaluate the effect on airway hyperresponsiveness and safety of multiple doses of XKH001 injection in patients with allergic asthma.7

    Cmin,ss

    Measured: Day169

  7. To evaluate the effect on airway hyperresponsiveness and safety of multiple doses of XKH001 injection in patients with allergic asthma.8

    Cavg,ss

    Measured: Day169

  8. To evaluate the effect on airway hyperresponsiveness and safety of multiple doses of XKH001 injection in patients with allergic asthma.9

    AUC0-inf,ss

    Measured: Day169

  9. To evaluate the effect on airway hyperresponsiveness and safety of multiple doses of XKH001 injection in patients with allergic asthma.10

    AUC0-t,ss,

    Measured: Day169

  10. To evaluate the effect on airway hyperresponsiveness and safety of multiple doses of XKH001 injection in patients with allergic asthma.11

    Tmax,ss,

    Measured: Day169

  11. To evaluate the effect on airway hyperresponsiveness and safety of multiple doses of XKH001 injection in patients with allergic asthma.12

    t1/2,ss

    Measured: Day169

  12. To evaluate the effect on airway hyperresponsiveness and safety of multiple doses of XKH001 injection in patients with allergic asthma.13

    AUCtau,

    Measured: Day169

  13. To evaluate the effect on airway hyperresponsiveness and safety of multiple doses of XKH001 injection in patients with allergic asthma.14

    %AUCex

    Measured: Day169

  14. To evaluate the effect on airway hyperresponsiveness and safety of multiple doses of XKH001 injection in patients with allergic asthma.15

    λz,ss

    Measured: Day169

  15. To evaluate the effect on airway hyperresponsiveness and safety of multiple doses of XKH001 injection in patients with allergic asthma.36

    Vz,ss/F

    Measured: Day169

  16. To evaluate the effect on airway hyperresponsiveness and safety of multiple doses of XKH001 injection in patients with allergic asthma.16

    CLss/F

    Measured: Day169

  17. To evaluate the effect on airway hyperresponsiveness and safety of multiple doses of XKH001 injection in patients with allergic asthma.17

    MRT;

    Measured: Day169

  18. To evaluate the immunogenicity, PK characteristics, and PD characteristics of multiple doses of XKH001 injection in patients with allergic asthma.20

    LYM ratios in sputum;

    Measured: Day169

  19. To evaluate the immunogenicity, PK characteristics, and PD characteristics of multiple doses of XKH001 injection in patients with allergic asthma.22

    Whole blood EOS count

    Measured: Day169

  20. To evaluate the immunogenicity, PK characteristics, and PD characteristics of multiple doses of XKH001 injection in patients with allergic asthma.23

    Whole blood NEU count

    Measured: Day169

  21. To evaluate the immunogenicity, PK characteristics, and PD characteristics of multiple doses of XKH001 injection in patients with allergic asthma.24

    Whole blood LYM count

    Measured: Day169

  22. To evaluate the immunogenicity, PK characteristics, and PD characteristics of multiple doses of XKH001 injection in patients with allergic asthma.25

    Whole blood MON count;

    Measured: Day169

  23. To evaluate the immunogenicity, PK characteristics, and PD characteristics of multiple doses of XKH001 injection in patients with allergic asthma.26

    Levels of IL-25 in serum

    Measured: Day169

  24. To evaluate the immunogenicity, PK characteristics, and PD characteristics of multiple doses of XKH001 injection in patients with allergic asthma.27

    Levels of TARC in serum

    Measured: Day169

  25. To evaluate the immunogenicity, PK characteristics, and PD characteristics of multiple doses of XKH001 injection in patients with allergic asthma.28

    Levels of IL-8 in serum

    Measured: Day169

  26. To evaluate the immunogenicity, PK characteristics, and PD characteristics of multiple doses of XKH001 injection in patients with allergic asthma.29

    Levels of MIP1β in serum

    Measured: Day169

  27. To evaluate the immunogenicity, PK characteristics, and PD characteristics of multiple doses of XKH001 injection in patients with allergic asthma.30

    Levels of Eotaxin in serum

    Measured: Day169

  28. To evaluate the immunogenicity, PK characteristics, and PD characteristics of multiple doses of XKH001 injection in patients with allergic asthma.31

    Levels of CXCL1 (KC/GROα) in serum

    Measured: Day169

  29. To evaluate the immunogenicity, PK characteristics, and PD characteristics of multiple doses of XKH001 injection in patients with allergic asthma.32

    Levels of Eotaxin-3 in serum

    Measured: Day169

  30. To evaluate the immunogenicity, PK characteristics, and PD characteristics of multiple doses of XKH001 injection in patients with allergic asthma.33

    Levels of IL-4 in serum

    Measured: Day169

  31. To evaluate the immunogenicity, PK characteristics, and PD characteristics of multiple doses of XKH001 injection in patients with allergic asthma.34

    Levels of IL-5 in serum

    Measured: Day169

  32. To evaluate the immunogenicity, PK characteristics, and PD characteristics of multiple doses of XKH001 injection in patients with allergic asthma.35

    Levels of IL-13 in serum;

    Measured: Day169

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2025
  2. Study start26 Dec 2023
  3. Primary completion10 Oct 2024
  4. Study completion20 Dec 2024

Resources

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
Not applicable
Intervention model
Single group
Model description
The screening period will not be more than 28 days (i.e., 4 weeks). The treatment period will be 12 weeks, and the follow-up period will be 12 weeks. All recruited patients with allergic asthma will undergo various screening procedures within 28 days prior to the first dose, and those who pass the screening will be sequentially enrolled. Patients who are enrolled in the study will be admitted to the study site on the day before each scheduled dose (D-1, D28, and D56) to complete the necessary pre-dose safety assessments and receive XKH001 subcutaneous (SC) injections on D1, D29, and D57. The patient will undergo regular safety assessment procedures (AE/SAE, vital signs, physical examination, laboratory tests, 12-lead electrocardiogram (ECG), etc.), FeNO, pulmonary function tests (FEV1 PD20 Mch), sputum induction, and other blood sample collections (PK, PD, and ADA) during the treatment period (D1-D85) and the subsequent 12-week follow-up period (\~D169).
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07070297
Sponsor's protocol ID
XKH001-01-Ic
Status last verified
Jun 2025
First submitted
23 Dec 2024
Last updated
17 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing XKH001 Injection in people with Asthma Patients, run by Zhejiang 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 9 inclusion and 20 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 17 Jul 2025. 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. 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?

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?

To evaluate the effect on airway hyperresponsiveness and safety of multiple doses of XKH001 injection in patients with allergic asthma. (time frame: Day43, Day85). The study lists 3 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 NCT07070297.

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 17 Jul 2025.

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