Oncology
Conditions
Interventions
SAD stage ST114 group:Six dose groups (4 mg, 12 mg, 36 mg, 80 mg, 120mg, 160 mg) will perform intravenous infusion
SAD stage placebo group:Six dose groups (4 mg, 12 mg, 36 mg, 80 mg, 120mg, 160 mg) will perform intravenous infusion of 5% glucose solution
MAD stage ST114 group:One dose group (160mg) will perform intravenous infusion
MAD stage placebo group:One dose group (160mg) will perform intravenous infusion of 5% glucose solution
Sponsors
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and female participants aged 18-45 years; 2. Body weight >= 50.0 kg (male) or >= 45.0 kg (female); Body Mass Index (BMI) 19.0-26.0 kg/m^2; 3. Must agree not to attempt to become pregnant, must not donate ova or sperm, and must agree to use highly effective method(s) of contraception throughout the study and at least 90 days after the last dose of study drug; 4. Have a full understanding of the objectives, nature, procedures, and possible AEs of the trial; and are able to communicate effectively with the Investigators, comply with all protocol requirements, and have signed the informed consent form (ICF) prior to any study procedures.
Exclusion criteria
Exclusion criteria: 1. Individual with a known history of specific allergies (e.g., urticaria) or a predisposition to allergic reactions (such as known allergies to two or more drugs), or known allergy to ST114 or its excipients (e.g., Tween 80, ethanol); 2. History of chronic or severe diseases including but not limited to circulatory, digestive, urinary, respiratory, hematologic, endocrine/metabolic (including diabetes), immune, nervous system from 1 year before screening to the date of enrollment; 3. Any clinically significant abnormal results of physical examination (ear temperature, pulse, respiratory rate, and blood pressure), laboratory tests (Hematology, Urinalysis, Clinical chemistry, Coagulation function, Immune tests, Virology tests), posteroanterior chest X-ray, abdominal ultrasound, or 12-lead ECGs during the screening period, as judged by the Investigator; 4. History or family history of congenital long QT syndrome; or have QTcF interval >=450 ms (male) or >=470 ms (female) on 12-lead ECG; 5. Engaged in occupations involving high-altitude work, driving, or other related activities; 6. History of chronic infection, recurrent infection, latent infection, or an acute illness from 2 weeks before screening to the date of enrollment; 7. Have used any prescription, nonprescription drugs, herbal remedies or dietary supplements from 2 weeks before screening to the date of enrollment; 8. Have used any medications known to inhibit or induce hepatic drug metabolism (e.g., inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids; Inhibitors: selective serotonin reuptake inhibitors (SSRIs), cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines, omeprazole) from 30 days before screening to the date of enrollment; 9. Unable or unwilling to refrain from any food or beverage that containing caffeine (e.g., chocolate, tea, coffee, cola, etc.), or affect drug metabolism (e.g., grapefruit, grapefruit products, dragon fruit, mango, pomelo, starfruit, guava, etc.) from 48 hours prior to the first dose until the end of the study; 10. Have undergone major surgery (excluding diagnostic surgeries) from 6 months before screening to the date of enrollment, or planned to undergo surgery during the study, or received surgeries might affect drug absorption, distribution, metabolism, or excretion (ADME) judged by the Investigators; 11. Have received live or live-attenuated vaccine from 2 weeks before screening to the date of enrollment; 12. Have participated in any other clinical trial from 3 months before screening to the date of enrollment, or who participate in this study on behalf of another individual; 13. Blood donation or significant blood loss with a volume of >= 400 mL (excluding physiological menstrual loss in females) within 6 months prior to screening, or donated blood from 3 months before screening to the date of enrollment, or who plan to donate blood during the study or within 3 months after the end of the study; 14. History of alcohol abuse or excessive alcohol consumption, defined as more than 14 units per week from 12 months before screening to the date of enrollment (one unit is equivalent to 5° beer , 45 mL of 40° spirit, or 150 mL of 12° wine ); or unable to abstain from alcohol or alcohol-containing products during the study; 15. Have a positive result for alcohol breath test (>0.0 mg/100 mL) at screening; 16. History of heavy smoking or smoking more than 5 cigarettes per day on av
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event;Vital signs;physical examinations;laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function);12-lead ECG; | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics parameters of parent drug ST114 and its metabolites in plasma: Cmax, AUC0-t, AUC0-8, Tmax, t1/2, MRT0-t, MRT0-8, CL, V, ?z; | — |
Countries
China
Contacts
Public ContactYing Wang
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Outcome results
None listed