Fibrosing Interstitial Lung Disease (Control Pulmonary Fibrosis)
Conditions
Interventions
Single-dose group:Single dosing
Repeated dose group:Repeated dosing
Sponsors
Shulan (Hangzhou) Hospital Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 18 to 55 years (including 18 and 55 years old); 2. Sign the informed consent form before the test, and fully understand the test content, process and possible adverse reactions; 3. Able to complete the research in accordance with the requirements of the test plan; 4. Subjects (including partners) are willing to take effective contraceptive measures voluntarily within 12 months from the screening to the last study drug administration; 5. The weight of male subjects is not less than 50 kg, and the weight of female subjects is not less than 45 kg. BMI is within the range of 18-28 kg/m2 (including the critical value); 6. Physical examination and normal or abnormal vital signs have no clinical significance.
Exclusion criteria
Exclusion criteria: 1. Allergies (multiple drugs and food allergies); 2. A history of drug and/or alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); 3. Donate blood or lose a lot of blood (> 450 mL) within 3 months before screening; 4. Have taken research drugs or participated in drug clinical trials within 3 months before screening; 5. People who smoked more than 5 cigarettes per day in the 3 months before screening; 6. Take any drugs that change liver enzyme activity 28 days before screening; 7. Take any prescription drugs, non-prescription drugs, any vitamin products or herbal medicines within 14 days before screening; 8. Have taken a special diet (including dragon fruit, mango, grapefruit, lime, carambola, etc. or foods or beverages prepared by them) within 14 days before screening; or consumed excessive amounts of tea, coffee or caffeine-rich beverages, Special diets such as xanthine-containing foods or beverages that affect drug absorption, distribution, metabolism, and excretion; or strenuous exercise; 9. There have been major changes in diet or exercise habits recently; 10. Abnormal ECG has clinical significance; or ECG QTc for males > 470 ms, females > 480 ms, the QTc calculation method adopts the Bazett method QTcB = QT/(RR^0.5), RR is the standardized heart rate value, obtained by dividing 60 by the heart rate 11. The following diseases (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, etc.) whose abnormal clinical laboratory examinations have clinical significance or other clinical findings within 12 months before screening have clinical significance , Immune, mental or cardiovascular and cerebrovascular diseases); 12. Viral hepatitis (including hepatitis B and C), AIDS antibody, Treponema pallidum antibody screening is positive; 13. The investigator believes that there are other subjects who are not suitable for participating in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical examination;Clinical laboratory examination;Vital signs;12-lead ECG;PK parameters; | — |
Countries
China
Contacts
Public ContactYin Hanwei
Shanghai Yuanxi Medicine Corp.
Outcome results
None listed