undetermined
Conditions
Interventions
single arm:T610
Sponsors
Shanghai Xuhui Central Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Willing to participate in the study, sign ICF, and follow the study procedure according to protocol; 2. Age 18-70 years old (included); 3. Body weight for males >= 50 kg, and body mass index (BMI) between 19 and 26 kg/m2(included); 4. No medical history of heart, liver, kidney, digestive tract, nervous system diseases and metabolic abnormalities; or chronic disease that does not affect the study judged by study doctors; 5. Normal vital signs, physical examination, results of laboratory tests, and ECG, or abnormality with no clinical significance; 6. Good venous conditions for establishing blood collection channels according to the study protocol; 7. No birth and sperm donor plan during the study period, willing to use effective contraceptive measures during the study and within 3 months after administration of investigational product.
Exclusion criteria
Exclusion criteria: 1. Taking any prescription medicine (except medicine for chronic disease that does not affect the study), Chinese herbal medicine, OTC medicine (except paracetamol used occasionally and sparingly), or health care products (except routine vitamin supplement) within 2 weeks before administration; 2. Positive results of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody; 3. History of any malignancy; 4. Participation in any drug or device clinical study within 3 months before administration; 5. Blood donation >= 400 mL within 3 months before administration, or blood loss >= 400 mL due to any reason; 6. Allergy to investigational product or any excipient; 7. Frequent drinkers within 3 months before administration, who drink more than 21 units of alcohol per week (1 unit =360 mL beer or 45 mL spirits with a 40% alcohol content or 150 mL wine), or positive alcohol test; 8. Positive urine drug abuse screening; 9. Smoking more than 10 cigarettes per day within 3 months before administration, or unwilling to comply with the smoking prohibition during the study period; 10. Having any other condition that study doctors consider inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma drug concentration; | — |
Countries
China
Contacts
Public ContactChen Yu, Gangyi Liu
Shanghai Xuhui Central Hospital
Outcome results
None listed