None listed
Conditions
Interventions
Low-dose group:Single oral administration
High-dose group:Single oral administration
placebo group:Oral placebo
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy adult male and female subjects ; 2. Age: 18-45 years old (including boundary values); 3. Body weight: Body mass index (BMI) should be between 19.0 and 26.0 kg/m2 (including the boundary value), the body weight of male subjects should not be less than 50 kg, and the body weight of female subjects should not be less than 45 kg; 4. Voluntarily sign the informed consent; 5. The subject can communicate well with the investigator and complete the experiment according to the protocol.
Exclusion criteria
Exclusion criteria: 1. Abnormal physical examination, vital signs, laboratory tests and other tests with clinical significance; 2. Patients with clinically significant hyperkalemia, hypokalemia, hypermagnesia, hypomagnesemia, hypercalcemia, or hypocalcemia as determined by the investigator as abnormal; 3. For abnormal 12-lead ECG results with clinical significance, QTcF>= 450 ms and PR interval >= 200 ms; QRS wave group duration >= 120ms; 4. Hepatitis B surface antigen or hepatitis B core antibody, hepatitis C antibody, HIV antibody or syphilis antibody positive; 5. The use of any drug that inhibits or induces liver drug-metabolizing enzymes within 30 days prior to the screening period; 6. Use of any known QT prolongation agent within 30 days prior to the screening period; 7. Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines or food supplements, such as vitamins and calcium supplements, within 14 days prior to the screening period; 8. Any history of clinically serious illness or disease or condition that the investigator believes may affect the results of the trial, including but not limited to a history of circulatory, respiratory, endocrine, nervous, digestive, urinary, or hematological, immune, psychiatric, and metabolic disorders; 9. A history of any conditions that may affect drug absorption, such as gastrectomy, cholecystectomy, gastric bypass, duodenotomy, colectomy, inflammatory bowel; 10. history of patients with organic heart disease, heart failure, history of myocardial infarction, angina pectoris history, history of coronary artery bypass, history of angioplasty and stent history, history of congestive heart failure, history of non-control low blood pressure, left ventricular ejection fraction is lower than the lower limit of normal part history, can not explain the history of history of cardiac arrhythmias, ventricular tachycardia, atrioventricular block, prolong the heald QT Concomitant history or family history of QT prolongation syndrome (indicated by genetic evidence or sudden cardiac death in a close relative at a young age); 11. Patients who have undergone any surgery within 6 months before the screening period; 12. Allergic constitution, such as a known history of allergy to two or more substances; Or may be allergic to the trial drug or its excipients (e.g., lactose T80, silica, sodium stearate, etc.) as judged by the investigator; 13. Heavy drinking or regular drinking in the 6 months prior to the screening period, i.e. drinking more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine); Or a positive alcohol breath test result during the screening period; 14. Users who used nicotine-containing products between 3 months before screening and study participation; 15. Those with a history of drug abuse or drug use within 3 months before the screening period; Or positive urine drug test during the screening period; 16. Those who habitually consume grapefruit juice or excessive tea, coffee and/or caffeinated beverages and are unable to abstain during the trial period; 17. Patients with a history of needle sickness and blood sickness, difficulty in blood collection or intolerance to venipuncture blood collection; 18. Participated in any other clinical trials (including drug and device trials) within 3 months prior to the screening period; 19. Those who had been vaccinated within 1 month before screening or planned to be vaccinated during t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline and placebo adjusted QTcF interval (??QTcF), and the upper 90% two-side confidence interval of ??QTcF corresponding to the geometric mean of Cmax at clinically relevant doses of FCN-437c capsule was evaluated by the C-QTc effect model.; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events;physical examination;vital signs;electrocardiogram monitoring;12-lead electrocardiogram;imb lead electrocardiogram;holter; | — |
Countries
China
Contacts
Public ContactLi Haiyan
Peking University Third Hospital
Outcome results
None listed