None
Conditions
Interventions
Single-dose 0.1 mg/kg:i.v. 0.1 mg/kg,Once daily
Single-dose 0.25 mg/kg:i.v. 0.25 mg/kg,Once daily
Single-dose 0.5 mg/kg:i.v. 0.5 mg/kg,Once daily
Single-dose 1 mg/kg:i.v.1 mg/kg, Once daily
Single-dose2 mg/kg:i.v. 2 mg/kg, Once daily
Single-dose 3 mg/kg:i.v. 3 mg/kg, Once daily
Single-dose 4 mg/kg:i.v. 4 mg/kg, Once daily
Multiple-dose 0.75 mg/kg:i.v. 0.75 mg/kg, qd, 8 days
Multiple-dose 1.5 mg/kg:i.v. 1.5 mg/kg, qd, 8 days
Multiple-dose 2.5 mg/kg:i.v. 2.5 mg/kg, qd, 8 days
Single-dose placebo-control:i.v. placebo, once daily
Multiple-dose placebo-control:i.v. placebo, qd, 8 days
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Chinese male or female subjects, with an equal number of males and females; 2.Aged 18 to 60 years (inclusive) at the time of signing the informed consent form; 3.Males with a body weight>=50.0 kg, females with a body weight >=45 kg; body mass index (BMI) between 19.0 and 26.0 kg/m² (inclusive); 4. Capable of understanding the informed consent form, willing to participate, and able to sign the informed consent form; 5. Capable of complying with the study protocol to complete the trial. Subjects who do not meet any of the above conditions shall not be enrolled as subjects.
Exclusion criteria
Exclusion criteria: 1. Subjects with clinically significant abnormalities in vital signs, physical examinations, 12-lead electrocardiogram, X-ray chest radiograph (posteroanterior view), abdominal ultrasound, and laboratory tests (including blood routine, urinalysis, blood biochemistry, coagulation function, immunoglobulin, lymphocyte subsets, thyroid function, etc.) as determined by the investigator during the screening period; 2. Subjects with a history of any clinically severe diseases in the hematological, circulatory, digestive, urinary, respiratory, nervous, immune, endocrine systems, malignant tumors, mental disorders, skin abnormalities, metabolic disorders, or known severe bleeding tendencies, or any other diseases or physiological conditions that may interfere with the trial results (determined by medical history inquiry); 3. Subjects with habitual constipation, difficulty in defecation or urination, etc., who are deemed unsuitable for enrollment by the investigator; 4. Subjects with a history of drug and/or food allergy, or known allergy to any component of the drug (including active ingredients and excipients used in the preparation), or subjects who are considered by the investigator to be at risk of allergy and unsuitable for enrollment; 5. Subjects with a history of tuberculosis or evidence of active tuberculosis, or those with clinically significant results in T-SPOT.TB (or QFT) testing; 6. Subjects with one or more clinically significant abnormalities in hepatitis B five markers, anti-hepatitis C antibody, anti-treponema pallidum antibody, or anti-human immunodeficiency virus antibody tests; 7. Subjects with positive drug screening [including morphine, methamphetamine, ketamine, ecstasy (3,4-methylenedioxymethamphetamine), cannabis (tetrahydrocannabinolic acid)]; 8. Subjects with a history of drug use within the past 3 years; 9. Subjects with a history of drug abuse within the past 2 years (including the use of prohibited substances and controlled drugs); 10. Subjects who have undergone surgery within 3 months prior to screening or plan to undergo surgery during the trial, and those who have undergone surgery that may affect drug absorption, distribution, metabolism, or excretion; 11. Subjects who participated in any clinical trial and received trial drugs as subjects within 3 months prior to screening; 12. Subjects who donated blood (including component blood) or had significant blood loss (>=200 mL), received blood transfusion, or used blood products within 3 months prior to screening; 13. Subjects who smoked excessively (average >5 cigarettes/day) within 3 months prior to screening, or who cannot commit to stopping the use of any tobacco products during the trial; 14. Subjects with positive nicotine screening; 15. Subjects who consumed more than 14 units of alcohol per week within 3 months prior to screening (1 unit of alcohol ˜ 360 mL of beer, 45 mL of 40% alcohol spirits, or 150 mL of wine), or who cannot commit to abstaining from alcohol during the trial; 16. Subjects with a breath alcohol test result > 0.0 mg/100 mL; 17. Subjects who received vaccines within 4 weeks prior to screening; 18. Subjects who took any prescription drugs, over-the-counter drugs, functional vitamins, or traditional Chinese herbal products within 14 days prior to screening; 19. Subjects with a history of long-term excessive consumption of tea, coffee, or caffeinated beverages (average >8 cups per day, 1 cup = 250 mL); 20. Subjects who engaged in strenuous exe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;safety;tolerability; | — |
Countries
China
Contacts
Public ContactLu hongzhou
Shanghai Public Health Clinical Center
Outcome results
None listed