None
Conditions
Interventions
Single Dose Group:Orally administration of SYN045 tablets (0.2,0.4,0.8,1.2,1.6, 2.2, 3 mg) or placebo once under fasting condition.
Food Effect Study:Seven of these subjects completed a single dose under fasting condition in the first cycle and, after a 7-day washout period, completed a single dose with a high-fat meal in the seco
Sponsors
The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Healthy subjects, male and female (both male and female), aged 18~45 years old (including boundary value); 2) The weight of male subjects = 50.0 kg, the weight of female subjects = 45.0 kg, and the body mass index (BMI) was within the range of 19~26 kg/m2 [BMI = weight (kg)/height 2 (m2)] (including boundary value); 3) Subjects (including male subjects and their female partners) are willing to have no fertility plan and voluntarily take effective non-drug contraceptive measures (see Appendix) from 2 weeks before screening to 6 months after the last dose and have no sperm donation and egg donation plans; 4) The subject signed a written informed consent form before screening, and fully understood the content, process and possible adverse reactions of the study, and was able to complete the study in accordance with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1) Diseases that need to be excluded due to abnormal clinical manifestations that occur or are occurring before screening, including but not limited to circulatory system, endocrine system, nervous system, digestive system, respiratory system, blood and lymphatic system, urinary system, endocrine system, immune system diseases, or any other diseases that can interfere with the test results (such as: movement disorder, history of convulsions, depression, angle-closure glaucoma, etc.); 2) Those with chronic or active digestive tract diseases in the past, such as gastrointestinal perforation, gastrointestinal fistula, esophageal disease, gastritis, peptic ulcer, enteritis, gastroesophageal reflux, pancreatitis, active gastrointestinal bleeding or gastrointestinal surgery, or body weight change of more than 10% within 3 months before administration; 3) Those who have gastrointestinal symptoms (diarrhea, constipation, nausea, vomiting, irregular bowel movements, or alternating episodes of diarrhea and constipation) within 7 days before screening, and the investigator believes that it is not suitable to participate in the experiment; 4) Those who have had a history of skin lesions or melanoma with unknown diagnosis in the past; 5) Those with a history of hypotension in the past; 6) Those who have had severe coronary heart disease or unstable angina pectoris in the past, or have had myocardial infarction in the past 6 months, or have decompensated heart failure, or have severe arrhythmia, or have congenital or acquired valve defects and other heart diseases related to myocardial function diseases and unrelated to pulmonary hypertension, or have had cerebrovascular events (such as transient ischemic attack, stroke) in the past 3 months; 7) Those who have a history of allergies to drugs, food or other substances in the past, and are prone to allergies; 8) Those who have undergone surgery within 3 months before screening or plan to undergo surgery during the study, and those who have undergone surgery that will affect the absorption, distribution, metabolism and excretion of drugs; 9) Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, health products and vitamins within 14 days before screening; 10) Those who have used any drugs that inhibit or induce hepatic drug metabolism within 30 days before screening (such as: inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); strong inhibitors of CYP2C8 (such as gemfibrozil); 11) Those who have enrolled in other drug clinical trials within 3 months before screening, or plan to participate in other drug clinical trials during the study period; 12) Those who donated blood within 3 months before screening, including component blood or large blood loss (=400mL); 13) Those who cannot tolerate venipuncture, or have a history of needle sickness or blood sickness; 14) Those who have used oral contraceptives within 30 days before screening, or those who have used long-acting estrogen or progestogen injections or implants within 6 months before screening; 15) Women who are lactating and pregnant, or women who have had unprotected sex within 14 days before screening; 16) Those who have special dietary requirements, cannot accept a unified diet, or have difficulty swallowing; 17) Those who drank e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of any adverse events that occurred during the clinical study in the subject; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK outcomes; | — |
Countries
China
Contacts
Public ContactWei Hu
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed