A Single-arm, Open-label, Single-dose, Phase I Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Recombinant Human Thrombopoietin for Injection (rhTPO) in Healthy Caucasian Volunteers

Exclusion Criteria21

• History of hypersensitivity to components of study drug or analogs; history of anaphylaxis or other significant allergy in opinion of the investigators.
• Known allergy to heparin or history of heparin-induced thrombocytopenia;
• Received a platelet transfusion within 2 weeks or platelet-boosting medication within 4 weeks prior to dosing;
• History of hospitalization or surgical procedure within 3 months prior to dosing, or bleeding from trauma or internal bleeding greater than 100 mL, or donating more than 100 mL of blood;
• History or presence of autoimmune disease, malignancy, thromboembolic disease, bleeding disorders, cardiovascular, hepatic, renal, muscular, hematopoietic, respiratory, neurological, or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk to the participant when taking the study drug; or interfering with the interpretation of data judged by the investigator;
• Note: Uncomplicated cholecystectomy and appendectomy are permitted; History of fully resolved childhood asthma is not permitted.
• History or presence of chronic diseases such as hypertension and diabetes (including type 1 and type 2 diabetes);
• History of malignancy with the exception of successfully treated basal cell or squamous cell skin cancer with no evidence of recurrence for 5 years.
• History of platelet clumping that prevents reliable measurement of platelet counts;
• Positive for Hepatitis B surface antigen (HBsAg), Hepatitis C Virus (HCV) antibody and Human Immunodeficiency Virus (HIV) antibody, Syphilis antibody;
• Note: Participants with positive hepatitis C antibody can be enrolled if a confirmatory negative hepatitis C RNA test is obtained.
• Use of prescription medication within 14 days prior to dosing and 7 days prior to dosing for over the counter medication/vitamins/herbal supplements (with the exception of contraception, occasional paracetamol < 2g/day, and standard dose of multivitamins).
• Consuption of alcohol, caffeinated products (coffee, tea, cola, chocolate), grapefruit fruits, or products containing grapefruit within 48 hours prior to dosing;
• Consuption of any poppy seeds (e.g., orange and poppy seed muffin, poppy seed bread) within 48 hours prior to screening and admission.
• History of drug abuse within 2 years prior to dosing; or positive alcohol/urine drug screen prior to dosing; Regular alcohol consumption within 6 months prior to dosing, i.e., on average more than 14 units of alcohol per week (1 unit = 360mL of beer or 45mL of spirits at 40% alcohol by volume or 150mL of wine);
• Use of tobacco or nicotine products equivalent to more than 2 cigarettes a day on average within 3 months prior to dosing;
• Have special dietary requirements and are unable to comply with the diet offered and the corresponding regulations;
• Pregnant or breastfeeding female, or positive pregnancy test;
• Individuals who cannot tolerate venipuncture or who suffer from needle and bloodsickness;
• Participation in another clinical study of investigational drug within 3 months prior to dosing;
• Other participants judged by the investigator to be unsuitable for participation.