Duchenne Muscular Dystrophy
Conditions
Interventions
1:2mg/kg dose, first in fasted condition and then in fed condition after 4 days cleaning period
2:2mg/kg dose, first in fed condition and then in fasted condition after 4 days cleaning period
3:6mg/kg dose, first in fasted condition and then in fed condition after 4 days cleaning period
4:6mg/kg dose, first in fed condition and then in fasted condition after 4 days cleaning period
Sponsors
Shanghai Xuhui Central Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: All of the following criteria should be met: 1) Subjects who voluntarily agree to participate in the clinical study and sign the informed consent form, and are willing and able to comply with all the study requirements; 2) Males aged 18-45 years (both inclusive) at the time of signing the informed consent form; 3) Subjects with body mass index (BMI) of 19.0-28.0 kg/m2 (both inclusive), and weight =50 kg; 4) Judged to be in good health by the Investigator on the basis of medical history, vital signs, physical examination, clinical laboratory tests (hematology, urinalysis, blood chemistry, coagulation test) and 12-lead ECG, etc.; 5) Being able to communicate with the medical staff normally and comply with the relevant management regulations of the hospital.
Exclusion criteria
Exclusion criteria: A subject meeting any of the following criteria will be excluded from the study: 1) Known or suspected to be allergic to glucocorticoids or any of their ingredients, and/or with a history of severe allergic disease or allergic constitution; 2) Subject with clinically significant gastrointestinal symptoms (e.g., nausea, vomiting, dyspepsia, gastrointestinal bleeding, acid reflux, constipation, and diarrhoea) and in the opinion of the Investigator, the subject is not suitable for entry into the study; 3) Previous or current history of serious cardiovascular, respiratory, hepatic, renal, gastrointestinal, psychiatric, neurological, or coagulation disorders, or malignant tumors, etc.; 4) Having undergone a major surgery within 6 months before signing the informed consent form, or planning to undergo a surgery during the study or within 1 month after the end of study; 5) Any liver function parameter (ALT, AST) or fasting blood glucose exceeding the upper limit of normal, which is judged by the Investigator as abnormal with clinical significance and remains abnormal with clinical significance upon retesting; 6) Resting heart rate 100 bpm; corrected QTc interval (Fridericia formula) = 450 ms or personal or family history of QT interval prolongation. If the QTc interval = 450 ms, and still considered abnormal with clinically significance by the Investigator upon retesting; 7) Systolic blood pressure =140 mmHg and/or diastolic blood pressure =90 mmHg; 8) Subjects who have tested positive for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) antibody or treponema pallidum antibody; 9) Addictions involving long-term alcohol intake and smoking, specifically: drinking more than 14 units of alcohol per week (1 unit=360 mL of beer, or 150 mL of wine, or 45 mL of liquor) or positive alcohol breath test at D-1; smoking more than 5 cigarettes or consuming an equivalent amount of nicotine or nicotine substitute per day; 10) Drink tea, coffee and/or caffeinated beverages in 24 h prior to the first dose; or habitually drink grapefruit juice (>8 cups per day, 350 mL/cup); 11) Currently using glucocorticoid preparations, or having used glucocorticoids systemically within 3 months prior to the first dose of investigational drug or topically within 2 months prior to the first dose of investigational drug; 12) Having used any prescription or non-prescription medications, traditional Chinese medicines, or nutritional supplements (other than vitamins and minerals) within14 days prior to the first dose of investigational drug; 13) Blood loss of more than 400 ml (inclusive) due to blood donation, surgery or other reasons within 90 days prior to the first dose of investigational drug; or donation of platelets, white blood cells or plasma within 15 days prior to the first dose of investigational drug; 14) Vigorous exercise, sunbathing or physical contact exercise (e.g., boxing, wrestling, etc.) within 96 h prior to admission to the hospital, and not being able to avoid such activities throughout the course of the study; 15) Having used any investigational medicinal product or participated in any clinical trial for medical devices within 3 months prior to the first dose of investigational drug; 16) Not agreeing to use any of the following effective contraceptive methods during the study and for 3 months after the end of study (see Appendix 3 for the contraceptive methods and requirements): a. Complete
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters AUC0-t;Pharmacokinetic parameters AUC0-8;Pharmacokinetic parameters Cmax;Pharmacokinetic parameters Tmax;Pharmacokinetic parameters t1/2;Pharmacokinetic parameters ?z;Pharmacokinetic parameters CL/F;Pharmacokinetic parameters Vz/F; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation measures:Any adverse events (AEs) and serious adverse events (SAEs);Vital signs;Physical examination;Laboratory tests;12-lead ECG; | — |
Countries
China
Contacts
Public ContactQian Chen
Shanghai Xuhui Central Hospital
Outcome results
None listed