none
Conditions
Interventions
A group:Take experimental drug- Take control drug
B group:Take control drug- Take experimental drug
Sponsors
The Second Affiliated Hospital Of Xingtai Medical College
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Chinese healthy adult male subjects; 2.Age 18~55 years old (including the boundary value) (on the date of signing the informed consent); 3.Weight >=50.0kg, body mass index [BMI= weight (kg)/height 2 (m2)] in 19.0~26.0kg/m2 (including the critical value); 4.The subjects voluntarily took effective contraception during the trial period and within 3 months after the trial ended, and had no plans to have children or donate sperm; 5.Subjects must be fully informed of this experiment and voluntarily sign a written informed consent; 6.The subjects were able to communicate well with the investigators and were able to complete the test according to protocol.
Exclusion criteria
Exclusion criteria: 1.During the screening period, vital signs examination, physical examination, laboratory examination (blood routine, urine routine, blood biochemistry, coagulation, IgE detection), abdominal ultrasound examination, chest X-ray and 12-lead electrocardiogram examination showed abnormal results and were judged by the investigator to be clinically significant; Reticulocyte, anemia three, transferrin saturation abnormal; 2.History of chronic or serious diseases of cardiovascular, liver, kidney, biliary tract, respiratory, blood and lymphatic, endocrine, immune, psychiatric, neuromuscular, gastrointestinal system within three years; 3.Have a history of specific allergies (such as urticaria) or are allergic (such as those who are known to be allergic to two or more drugs), or have a history of allergies to this ingredient or to human erythropoietin protein drugs; 4.People with past or current hypertension, stroke, thromboembolism, convulsion, epilepsy, or pure red cell aplastic anemia; 5.Persons with serious mental or mental illness; 6.Patients with a history of tumor; 7.The presence of other medical conditions that the investigator believes may affect the test results and the safety of the subject; 8.Patients who had surgery within 6 months prior to screening that the investigators determined would affect drug absorption, distribution, metabolism, or excretion, or who planned to have surgery during the study period; 9.Those who have received other biologics within 6 months prior to screening; 10.Persons with a history of drug abuse prior to the test (including non-medical use of narcotic drugs and psychotropic substances) or positive screening for drug abuse (including morphine, methamphetamine, ketamine, dimethylene dioxyamphetamine, THC, etc.); 11.Serum virology test (including hepatitis B surface antigen, hepatitis C antibody, AIDS antibody, syphilis specific antibody) any of the abnormal clinical significance; Blood loss of 400mL or more for other reasons in the 6 months prior to screening, or blood transfusion or use of blood products; 12.Blood loss of 400mL or more for other reasons in the 6 months prior to screening, or blood transfusion or use of blood products; 13.In the year prior to screening, there was a history of alcohol abuse, i.e. drinking more than 28 units of alcohol per week on average (1 unit =360 mL beer or 45 mL liquor with 40% alcohol or 150 mL wine), or alcohol breath test results greater than 0.0mg/100 ml; 14.In the past year, the average daily consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup ˜250mL); 15.Those who smoked >5 cigarettes per day in the 3 months before screening or could not smoke during the trial period; 16.Use of any medication (prescription, over-the-counter, vitamins, Chinese herbs, health products) in the 14 days or 5 half-lives prior to screening, whichever is longer; 17.Patients who had used systemic glucocorticoids within 3 months before screening; 18.Participants who had participated in other clinical trials within 3 months before screening; 19.Can not tolerate venipunctures or have a history of fainting needles and fainting blood; 20.Those who have special dietary requirements and cannot accept a unified diet; 21.Those who received the vaccine within 3 months before the first dose or plan to receive the vaccine during the study period or within 1 week after the end of the study; 22.Those with a low likelihood of enrollment or poor adherence, a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-8 for changes from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured value and change from baseline value t1/2z;AUC0-t for measured values and changes from baseline;Cmax of measured values and changes from baseline;Tmax of measured values and changes from baseline; | — |
Countries
China
Contacts
Public ContactFengxue GUO
The Second Affiliated Hospital Of Xingtai Medical College
Outcome results
None listed