Pharmacokinetics Comparison Study of JT1801 and NESP® After Single Dose Administration in Chinese Health Male Volunteers

Inclusion criteria

• Chinese healthy adult male subjects.
• Age of 18 to 55 years, inclusive.
• Subject with BMI between 19 kg/m2 and 26 kg/m2 (inclusive); and a total body weight ≥50 kg.
• Subject who agree to practive effective barrier contraception and avoid sperm donation during the entire study period and through at least 3 months after the last dose of study drug.
• Subject who provided written informed consent voluntarily after being fully informed of the study.
• Subject who is able to communicate well with the investigator and participate in the whole study process according to protocol.

Exclusion criteria

• During the screening period, vital signs measurement, physical examination, laboratory examination (blood routine, reticulocyte, urine routine, blood biochemistry, coagulation function, anemia, transferrin saturation, IgE detection), B-ultrasound examination, chest X-ray and 12-lead electrocardiogram examination showed abnormal results and were judged by the investigator to be clinically significant.
• History of chronic disease or serious disease in cardiovascular, liver, kidney, biliary tract, respiratory, blood, lymphatic, endocrinological, immunologic, psychiatric, neuromuscular, gastrointestinal system within three years.
• Have a history of specific allergies (e.g. hives) or are allergic (e.g. are known to be allergic to two or more drugs), or have a history of allergy to this ingredient or to EPO drugs.
• Subjects with past or present history of hypertension, stroke, thromboembolism, convulsion, epilepsy or pure red cell aplasia.
• Subject with severe psychological or mental illness.
• Subject with a previous history of tumors.
• The investigator considers that there are other medical conditions that may affect the study results and the safety of the subjects.
• Subject who had surgery within 6 months prior to screening period that the investigators determined would affect drug absorption, distribution, metabolism, or excretion, or who planned to have surgery during the study period.
• Subject who have received other biologics within 6 months.
• Those with a history of drug abuse (including the use of various narcotic drugs and psychotropic substances for non-medical destinations) or positive drug abuse screening (including morphine, methamphetamine, ketamine, dimethylenedioxyamphetamine, tetrahydrocannabinolic acid, etc.) before the test.
• Positive for any of the virological tests, including human immunodeficiency virus, hepatitis C antibody, hepatitis B surface antigen, and treponema pallidum antibody.
• Subjects who have donated blood or lost blood from other reasons within 6 months prior to screening with a total of 400mL or received blood transfusions or used blood products.
• Has a history of alcohol abuse within 1 year prior to screening, whereby drink more than 2 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.
• In the past year, the average daily consumption of excessive tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup ≈250mL).
• Those who smoked > 5 cigarettes per day within 3 months before screening or could not refrain from smoking during the test.
• Those who have used any drugs (prescription drugs, over-the-counter drugs, vitamins, Chinese herbal medicines, health supplements) within 30 days before enrollment.
• Those who have used systemic glucocorticoids within 3 months before enrollment.
• Those who have participated in other clinical trials within 3 months before enrollment.
• Those who cannot tolerate venipuncture or have a history of needle sickness and blood sickness.
• Those who have special requirements for diet and cannot accept a unified diet.
• Subjects who received the vaccine within 3 months prior to the first dosing, or plan to be vaccinated during the study or within 1 week after the last dosing.
• Those with a low probability of enrollment or poor adherence (such as frailty, physical exhaustion, dehydration or malnutrition, etc.) according to the judgment of the investigator.