Chronic heart failure
Conditions
Interventions
Single dose escalation versus multiple dose escalation:GD-N 1702capsules 10mg,once
SAD -20mg:GD-N 1702 capsules VS placebo=6:2,once
SAD-40mg:GD-N 1702 capsules VS placebo=6:2,once
SAD -80:GD-N 1702 capsules VS placebo=6:2
SAD -120:GD-N 1702 capsules VS placebo=6:2,once
SAD-180mg:GD-N 1702 capsules VS placebo=6:2,once
SAD-240mg:GD-N 1702 capsules VS placebo=6:2,once
MAD-20mg:20mg,qd 10Days
MAD -40mg:40mg,qd 10Days
MAD-120mg:120mg,qd 10Days
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Participants must meet all the following criteria to be included in the study: 1. Healthy adult male or female subjects aged 18-45 years at the time of screening (including boundary values, subject to the time of signing the informed consent); 2. Body mass index (BMI: weight [kg]/ height [m]2) in the range of 18.0 to 26.0 kg/m2 (including boundary values), male subjects weight >= 50 kg, female subjects weight >= 45 kg; 3. The vital signs, physical examination, laboratory examination and 12-lead electrocardiogram (ECG) results of the subjects during the screening period were normal or the abnormal results were not clinically significant; 4. Eligible subjects who are fertile must consent to use a medically approved contraceptive method (such as an intrauterine device, birth control pill, or condom) during and for 6 months after the trial, as specified in Appendix 1; No sperm/egg donation was planned during the trial period and within 6 months after the trial; 5. Subjects fully understand the purpose, nature, methods and possible adverse reactions of the trial, participate voluntarily and sign written informed consent, and complete the study in accordance with the protocol requirements.=
Exclusion criteria
Exclusion criteria: Subjects were excluded from the study if they met one or more of the following criteria: 1. A known severe allergy, non-allergic drug reaction or multidrug allergy, or known hypersensitivity reaction to a test drug (active API or pharmaceutical excipient); 2. The presence of symptoms or related history of any major diseases, including but not limited to heart, liver, kidney diseases or other acute and chronic digestive tract diseases, respiratory diseases, bone and joint diseases, blood, endocrine, neurological, mental and other systemic diseases, or any other diseases or physiological conditions that may interfere with the test results; Any surgical condition or condition that may significantly affect the absorption, distribution, metabolism, and excretion of drugs or that may pose a hazard to the subjects participating in the trial; Such as gastrointestinal surgery history (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary obstruction or dysuria, gastrointestinal ulcer, gastrointestinal bleeding history, etc. Note: Subjects who have undergone appendectomy or hernia repair may be enrolled in the study; 3. Current chronic liver disease or a history of known liver or biliary abnormalities that the investigator judged would affect the results of the trial; Patients whose liver function test results at screening were outside the normal range of the study site and whose abnormality was determined to be clinically significant by the investigator (two repeated assessments were allowed at the investigator's discretion); 4. Patients with current arrhythmia-like diseases (symptomatic or asymptomatic) or a history of arrhythmia-like diseases whose abnormality is determined by the investigator to be clinically significant; 5. Clinically significant ECG abnormalities, including but not limited to second - or third-degree AV block, QRS cluster prolongation of more than 120 msec, or QTc interval prolongation (QTcF>450 msec in male subjects and QTcF>470 msec in female subjects; see Appendix 2 for the formula); 6. Patients with systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg at the time of screening and were identified as clinically significant by the investigator; 7. Heart rate 100 beats/min during screening; 8. Clinically significant physical abnormalities; 9. Severe infections, including cellulitis, infectious pneumonia, and sepsis, occurred within 1 month before the first administration of the drug. For subjects with mild upper respiratory tract infection, the decision of the investigator can be made; 10. Receive treatment (such as physiotherapy, acupuncture, etc.) within 1 month before the first dose; 11. Received live vaccination within 1 month before the first dose; 12. Patients who had a clinically significant disease or underwent a major surgical procedure (except minor outpatient procedures) within 3 months before the first dose, or who expected to require major surgery during the trial; 13. Patients with difficulty in collecting blood or swallowing capsules; 14. Known or suspected history of drug abuse within 2 years before screening, or drug abuse within 3 months before screening, or positive drug abuse screening during screening and baseline; 15. Those who have used investigational drugs within 3 months before the first dose or plan to participate in other interventional clinical trials during the study; 16. Has used any prescription drugs (inclu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK; | — |
Countries
China
Contacts
Public ContactLuo Zhu
West China Hospital of Sichuan University
Outcome results
None listed