IgA Nephropathy
Conditions
Interventions
treatment group:SAL0120 Dapagliflozin
Sponsors
Shenzhen People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who have fully understood and voluntarily signed the informed consent form (ICF), and are able to abide by the requirements and restrictions specified in the ICF; 2. Healthy male or female adults aged 18 to 65 years (inclusive); 3. Body weight =50 kg for male subjects and =45 kg for female subjects at screening, with a body mass index (BMI) between 19.0 and 26.0 kg/m2 (inclusive; BMI = body weight ÷ height2); 4. No abnormalities or only slight abnormalities not clinically significant as judged by the investigator in all examinations (including physical examination, body temperature, pulse, hematology, urinalysis, blood chemistry, coagulation function, serum virology, electrocardiogram, and chest X-ray (posteroanterior view), etc.) at screening. Systolic blood pressure should be within the range of 90-139 mmHg (inclusive), diastolic blood pressure should be within the range of 60-89 mmHg (inclusive), and fasting blood glucose should be =3.9 mmol/L.
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of allergic diseases (e.g., asthma, urticaria, eczematous dermatitis, etc.) or known allergies to ETA receptor antagonists, sodium-glucose co-transporter 2 inhibitors, or the study drug and any of its excipients; 2. Subjects with any history or current diseases that could affect the safety evaluation of the subject or the pharmacokinetics of the study drug, including but not limited to diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematological system, immune system, psychiatric disorders, metabolic abnormalities, or those who have undergone gastrointestinal surgery (except for appendectomy); 3. Subjects with a history of diabetes, hypoglycemia, or hypotension; 4. Subjects with a history of ketoacidosis, genital fungal infections, or urinary tract infections; 5. Subjects who received live vaccines, or attenuated vaccines within 4 weeks prior to screening; 6. Subjects who consume excessive amounts of tea, coffee, and/or beverages containing caffeine (more than 8 cups per day, with 1 cup = 250 mL), or who have consumed tea, coffee, and/or beverages containing caffeine within 48 hours prior to dosing, or who cannot refrain from consuming these beverages during the study period; 7. Subjects with a history of long-term consumption of beverages or foods rich in xanthine or grapefruit, or who have consumed any products rich in xanthine or grapefruit within 48 hours prior to dosing; 8. Subjects who used any drugs that inhibit or induce hepatic drug metabolism within 28 days prior to screening (e.g., inducers such as barbiturates, carbamazepine, phenytoin sodium, rifampicin, etc.; inhibitors such as SSRIs, cimetidine, cyclosporin, macrolides, verapamil, quinolones, azole antifungals, HIV protease inhibitors, etc.); 9. Subjects who used any prescription drugs, over-the-counter medications, Chinese herbal medicines, or health-care supplements within 14 days prior to screening; 10. Subjects and their spouses or partners who have plans to conceive, donate sperm or eggs during the study period and up to 3 months after dosing, or who do not agree to use at least one of the following acceptable and effective contraceptive methods: a) Properly placed intrauterine devices (IUD); b) Male/female condoms used concurrently with spermicidal agents (e.g., foam, gel, film, cream, or suppository); c) Male sterilization via vasectomy or vasoligation; d) Female sterilization via bilateral tubal ligation/bilateral salpingectomy or bilateral tubal occlusion (with occlusion confirmed by appropriate instrumentation); e) Abstinence. 11. Pregnant or lactating women, or women of child-bearing potential (WOCBP) with a positive pregnancy test at screening; 12. Subjects with a positive result for any of the following tests: hepatitis B surface antigen test, hepatitis C antibody test, HIV test, and treponema pallidum antibody test; 13. Smokers or subjects with an average tobacco consumption of more than 5 cigarettes per day within 3 months prior to screening, or those who could not completely stop consuming tobacco products during the study; 14. Subjects with an alcohol consumption of more than 14 units per week (1 unit ˜ 360 mL of beer or 45 mL of spirit with 40% alcohol content or 150 mL of wine) within 3 months prior to screening, or with a positive result for breath alcohol test at screening, or those who could not completely stop consuming alcohol-containing food or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax,ss;AUC0-tau,ss; | — |
Secondary
| Measure | Time frame |
|---|---|
| tmax,ss;Cav,ss;Ctrough;t1/2,ss;CL/F,ss; | — |
Countries
China
Contacts
Public ContactHongying Yang
Shenzhen People's Hospital
Outcome results
None listed