XKH001 Injection in Healthy Subjects

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Beijing Kanova Biopharmaceutical Co., LTD

Criteria

Inclusion Criteria:

1. Healthy subjects who voluntarily sign a written informed consent form (ICF) and are able to complete the study as required by the protocol;

2. Male or female subjects aged 18 to 65 years (inclusive);

3. Subjects with BMI between 18 and 28 kg/m2 (inclusive);

4. Subjects with normal or abnormal but not clinically significant results of vital signs, physical examinations, laboratory tests, 12-lead ECGs and QTcF ≤ 450 ms;

5. Subjects who did not use any prescription or over-the-counter medications within two weeks prior to dosing;

6. 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 Criteria:

1. Pregnant or lactating women;

2. 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.;

3. Subjects with history of autoimmune diseases, known family history of inherited immunodeficiency disorders, or recurrent infections suggestive of possible immunodeficiency;

4. 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;

5. Subjects with a history of active tuberculosis or subjects with active or latent tuberculosis infection at screening;

6. 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;

7. Subjects who plan to receive live or live attenuated vaccines within 4 weeks prior to dosing or during the study;

8. 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;

9. 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;

10. 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;

11. 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;

12. Subjects who have a smoking history (> 5 cigarettes/day) within 3 months prior to screening;

13. 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;

14. Subjects with obstructed venous access or intolerance to venipuncture;

15. Subjects who are considered inappropriate for the study by the investigator.