Idiopathic Pulmonary Arterial Hypertension
Conditions
Interventions
1:6 mg MN-08 tablets
2:12 mg MN-08 tablets
3:24 mg MN-08 tablets
4:42 mg MN-08 tablets
5:60 mg MN-08 tablets
6:84 mg MN-08 tablets
7:low-dose MN-08
8:middle-dose MN-08
9:high-dose MN-08
Sponsors
Yanbian University Affiliated Hospital (yanbian Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 45 years (inclusive), both male and female; 2. Body weight of males >= 50 kg, body weight of females >= 45kg, and body mass index (BMI) 18.6~26.4 kg/m2 (inclusive). BMI = Weight (kg) / Height (m)2; 3. Right arm blood pressure with a sitting position should be within 90/60 mmHg to 139/89 mmHg, and pulse pressure should be within 30 to 69 mmHg when screening. Heart rate should be within 60/min to 100/min after 5 minutes rest. 4. Subjects must be fully understand the informed consent, study content, process and adverse reaction might risk in the trial prior to enrollment, and must voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. With an allergic constitution, or subject is known to have a history of allergies to research drug components, similar drugs or their excipients; 2. Subjects are found through clinical examination to have diseases with clinical significance in the context of this trial (including but not limited to respiratory, circulatory, gastrointestinal, hematologic, endocrine, immune, dermatologic, nervous, ENT and other related diseases); 3. Those who are suffering from gastrointestinal, liver and kidney diseases that can affect the pharmacokinetic profiles of drugs; 4. Any vital signs, physical examinations, electrocardiograms, laboratory tests, X-ray, B-mode ultrasound, and cardiac color ultrasound show abnormal clinical significance (for example, a creatinine value above the normal upper limit and/or a liver function test (ALT, AST, bilirubin) greater than 1.5x ULN); 5. Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), AIDS (HIV), and/or syphilis antibody (PT) positive; 6. Subjects who have undergone major surgery within 6 months prior to the first dose, or who plan to undergo surgery during the study period; 7. Have a history of drug abuse, those who have used drugs within 3 months prior to the first dose, or subjects who use drugs habitually, including Chinese herbal medicines; 8. Subjects who are heavy smokers or who smoke more than 5 cigarettes per day during the first 3 months of screening, or refuse to avoid the use of any tobacco products 24 hours before dosing and during hospitalization; 9. Subjects with a history of alcohol abuse up to 6 months before the study, i.e. consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer with 5% alcohol content, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine with 12% alcohol content), or those who refuse to stop alcohol intake 24 hours before dosing and during hospitalization, or those who have positive results during a breath alcohol test; 10. Have a habit of drinking excessive tea, coffee or caffeinated beverages (more than 8 cups, 250 mL each cup), or refuse to avoid the drinking of caffeine, grapefruit juice or poppy products 24 hours before and during the study; 11. Those who have lost blood or donated more than 200 mL within 3 months before the first dose, or 2 therapeutic doses of platelets within 1 month of the study (1 therapeutic dose = 12U platelets); 12. Those who have used any drug within 14 days prior to the first dose; 13. Taking any clinical trial drug within 3 months prior to the first dose; 14. Receiving any vaccination within 3 months prior to the first dose; 15. Subjects who plan to donate sperm or eggs within 6 months after signing the informed consent form; 16. Subjects have a pregnancy plan within 6 months from the date of informed consent and refuse to take effective contraceptive methods; 17. Subjects who may not be able to complete the study for other reasons or those the investigator believes should not be included. In addition to the above requirements, female subjects should also be excluded if they meet the following criteria: 18. Pregnant or lactating women or those with positive blood pregnancy test results; 19. Those who have used oral contraceptives within 30 days prior to the first dose; 20. Long-acting estrogen or progestin injections or implants used within 6 months prior to the first dose; 21. Women of childbearing age who have unprotected sex with their partner within 14 days prior to the f
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood routine examination;Blood biochemistry;Urine routine;Blood coagulation;pharmacokinetics;Vital signs;Physical examination;ECG; | — |
Countries
China
Contacts
Public ContactZhehu Jin
Yanbian University Affiliated Hospital (Yanbian Hospital)
Outcome results
None listed