None listed
Conditions
Interventions
Sponsors
Shanghai Xuhui Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Willing to participate in the study, sign ICF, and follow the study procedure according to protocol; 2. Age 18-45 years old (included); 3. Body weight for males >=50 kg, for femal>=45 kg and body mass index (BMI) between 18 and 28 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 drugs (except vaccine), Chinese herbal medicine, over-the-counter drugs (except occasional and limited use of paracetamol) and health products (except routine supplementary vitamins) 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. Pregnant or lactating women, or women of childbearing age with positive pregnancy test 11. Having any other condition that study doctors consider inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| baicalin and baicalein; | — |
Secondary
| Measure | Time frame |
|---|---|
| biomarker; | — |
Countries
China
Contacts
Public ContactYu Chen, Liu Gangyi
Shanghai Xuhui Central Hospital
Outcome results
None listed