Chronic Heart Failure
Conditions
Interventions
Single dose tolerance trial group(0.2ug/kg):Neuregulin-1 (NeucardinTM)was given a single dose of 0.2 ug/kg
Single dose tolerance trial group(0.4ug/kg):Neuregulin-1 (NeucardinTM)was given a single dose of 0.4 ug/kg
Single dose tolerance trial group(0.8ug/kg):Neuregulin-1 (NeucardinTM)was given a single dose of 0.8 ug/kg
Single dose tolerance trial group(1.2ug/kg):Neuregulin-1 (NeucardinTM)was given a single dose of 1.2 ug/kg
Single dose tolerance trial group(1.6ug/kg):Neuregulin-1 (NeucardinTM)was given a single dose of 1.6 ug/kg
Single dose tolerance trial group(2.4ug/kg):Neuregulin-1 (NeucardinTM)was given a single dose of 2.4 ug/kg
Single dose PK trial group:Neuregulin-1 (NeucardinTM)was given a single dose of 1.2 ug/kg
Consecutive dose tolerance and PK trial group(0.2ug/kg):Neuregulin-1 (NeucardinTM)was given for 5 consecutive days at 0.2 ug/kg
Consecutive dose tolerance and PK trial group(0.4ug/kg):Neuregulin-1 (NeucardinTM)was given for 5 consecutive days at 0.4 ug/kg
Consecutive dose tolerance and PK trial group(0.8ug/kg):Neuregulin-1 (NeucardinTM)was given for 5 consecutive days at 0.8 ug/kg
Consecutive dose tolerance and PK trial group(1.2ug/kg):Neuregulin-1 (NeucardinTM)was given for 5 consecutive days at 1.2 ug/kg
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy subjects; 2. For the subjects aged from 19 to 45, the age difference of the same group was not more than 10 years; 3. Subjects with body mass index (BMI) of 20-27 (BMI = the square of weight (kg) / height (m)); 4. The subjects with normal physical examination had no damage to heart, lung and other organs, and had no abnormal clinical significance in serology, liver and kidney function, blood and urine routine tests; 5. Subjects who understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with organic diseases of cardiovascular and cerebrovascular diseases, blood system, nervous system and other systems or with a history of the above systems; 2. Pregnant or lactating women and pregnant subjects; 3. Subjects who are taking other preventive or therapeutic drugs; 4. The subjects who donated blood and collected blood in recent 3 months; 5. Subjects who have used various drugs (including traditional Chinese Medicine) in the past two weeks; 6. Subjects who have participated in other drug trials in recent 3 months; 7. Subjects who have a habit of smoking and drinking; 8. Subjects with allergic constitution or history of drug allergy; 9. According to the judgment of the researcher, the subjects who are unable to complete the study or may not comply with the requirements of the study (due to management or other reasons).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tolerance and pharmacokinetics; | — |
Countries
China
Contacts
Public ContactMingdong Zhou
Zensun (Shanghai) Sci & Tech Co., Ltd.
Outcome results
None listed