High blood pressure
Conditions
Interventions
pre-experimental group :5mgMT-1207 single dose
group 1:5mgMT-1207/ placebo single dose
Group 2:10mgMT-1207/ placebo single dose
Group 3:20mgMT-1207/ placebo single dose
Group 4:40mgMT-1207/ placebo single dose
Group 5-A:60mgMT-1207/ placebo double dose
Group 5-B:60mgMT-1207/ placebo double dose
Group 6:90mgMT-1207/ placebo single dose
Group 7:Multiple doses of 20mg or 40mg MT-1207 / placebo multiple dose
Sponsors
Phase I Clinical Laboratory of the First Hospital of Jilin University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) sign the informed consent before the test, and fully understand the test content, process and possible adverse reactions; 2) be able to complete the study according to the requirements of the test program; 3) subjects (including partners) are willing to voluntarily take effective contraceptive measures within 6 months after screening to the last study drug administration. See appendix for specific contraceptive measures. 4) male and female subjects aged between 18 and 55 years (including 18 and 55 years); 5) the weight of male subjects should not be less than 50kg and that of female subjects should not be less than 45kg. Body mass index (BMI) = weight (kg)/height 2 (m2), body mass index in the range of 18~28kg/m2 (including the critical value); 6) normal or abnormal physical examination and vital signs have no clinical significance.
Exclusion criteria
Exclusion criteria: 1) smoking more than 5 cigarettes per day in the 3 months before the test; 2) allergic constitution (multiple drug and food allergies); 3) a history of drug abuse and/or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, 25 mL of spirits, or 100ml of wine); 4) blood donation or massive blood loss (> 450ml) within three months before screening; 5) any drug that changes liver enzyme activity 28 days before screening; 6) taking any prescription, over-the-counter, vitamin products or herbs within 14 days prior to screening; 7) those who have taken special diet (including dragon fruit, mango, grapefruit, etc.) or have strenuous exercise or other factors affecting drug absorption, distribution, metabolism and excretion within 2 weeks before screening; 8) combination of the following inhibitors or inducers of CYP3A4, p-gp or Bcrp, such as itraconazole, ketoconazole or jindalon; 9) recent major changes in diet or exercise habits; 10) have taken the study drug or participated in the drug clinical trial within three months prior to taking the study drug; 11) a history of dysphagia or any gastrointestinal illness that affects drug absorption; 12) any diseases that increase the risk of bleeding, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers; 13) subjects who cannot tolerate standard meal (two boiled eggs, one piece of buttered bacon toast, one box of Fried potato chips, one cup of whole milk) 14) abnormal ecg has clinical significance, QTC>450ms; 15) sit systolic blood pressure below 100 mmHg, and/or sit diastolic blood pressure below 60 mmHg; 16) postural hypotension occurred during screening. The diagnostic criteria are shown in appendix 8 of the clinical trial protocol. 17) patients with a history of postural hypotension or syncope; 18) female subjects are lactation or positive serum pregnancy results during the screening period or during the test; 19) the following diseases (including but not limited to gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardio-cerebrovascular diseases) that are clinically abnormal by clinical laboratory examination or clinically significant by other clinical findings within 12 months prior to screening; 20) positive screening for viral hepatitis (including hepatitis b and c), AIDS antibody and syphilis spirochete antibody; 21) acute illness or concomitant medication occurred from the screening stage to the pre-study medication; 22) ingestion of chocolate, any caffeinated or xanthine-rich food or drink 48 hours prior to taking the study drug; 23) having taken any alcoholic product within 48 hours prior to taking the study drug; 24) positive urine screening or drug abuse history or drug use in the past 5 years; 25) subjects considered by the investigator to have other factors unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerance indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic indicators; | — |
Countries
China
Contacts
Public ContactWang peng
Outcome results
None listed