Status:
UNKNOWN
XKH001 Injection in Healthy Subjects
Lead Sponsor:
Beijing Kanova Biopharmaceutical Co., LTD
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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 o...
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 1. 100 mg Q4W (D1, D...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05991661
Start Date
December 1 2023
End Date
December 1 2024
Last Update
November 3 2023
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