Safety, Tolerability, and PK/PD of Telpegfilgrastim Injection in Non-pregnant Females of Childbearing

Exclusion Criteria

• •1. Healthy, childbearing-age, non-pregnant women: Those with organic lesions in vital organs such as the heart, liver, kidneys, brain, and lungs; a clear history of diseases or other significant conditions affecting the central nervous system, cardiovascular system, cerebrovascular, hematological system, urinary system, digestive system, respiratory system, metabolic and musculoskeletal system; a history of autoimmune diseases; a history of endocrine disorders, such as thyroid dysfunction.
• •2. Healthy, childbearing-age, non-pregnant women: Those with gastrointestinal, liver, kidney, or other known diseases that interfere with drug absorption, distribution, metabolism, or excretion.
• •3. Suffering from malignant tumors or any history of any malignancy within 5 years prior to screening (except for completely resected carcinoma in situ of the cervix, non-metastatic cutaneous squamous cell carcinoma, or basal cell carcinoma).
• •4. History of organ transplantation or use of immunosuppressants agents within in the past 3 months or planned use, including but not limited to; calcineurin inhibitors such as tacrolimus and cyclosporine; mycophenolate agents such as mycophenolate mofetil and mycophenolate sodium enteric-coated tablets; glucocorticoids medications such as prednisone and methylprednisolone; others such as sirolimus, azathioprine, mizoribine and leflunomide;
• •5. A history of poorly controlled psychiatric disorders with medication.
• •6. Current or history of severe or persistent infection within the past 3 months (requiring hospitalization or opportunistic infections); or evidence of active and uncontrolled viral infections, such as HIV, HBV (HBsAg positive), HCV (anti-HCV antibody positive), syphilis, or any bacterial, parasitic, or fungal infection requiring treatment.
• •7. Allergy to rhG-CSF products (including rhG-CSF and PEG-modified rhG-CSF) and their components, or allergy to recombinant human proteins or polypeptide drugs derived from E. coli.
• •8. Use of human granulocyte colony-stimulating factor (G-CSF) therapies within the past 3 months prior to screening; planned or current use of drugs with potential drug interactions with G-CSF therapies, such as lithium;
• •9. Use of any prescription or over-the-counter drugs (including traditional Chinese medicine, health supplements, etc.) within 14 days before the first dose of the test drug or during the drug's 5 half-lives (whichever is longer), unless both the researcher and the sponsor agree that it has no impact on the clinical study.
• •10. Current or planned use of aspirin, statins, and/or any other drugs that affecting the pathogenesis of preeclampsia (including but not limited to low molecular weight heparin, broccoli sprout extract tablets, digoxin immune Fab, recombinant antithrombin III, proton pump inhibitors, metformin, etc.);
• •11. Vaccination with live or attenuated vaccines within 3 months before the start of the trial.
• •12. History of drug abuse, drug use, or alcoholism (drug abuse history or use of narcotics in the past five years; consumption of 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
• •13. Smoking (or use of tobacco products) in the past 3 months, or those who do not agree to refrain from smoking during the study period.
• •14. Participation in a clinical drug trial within 3 months before screening or 5 times the drug's half-life as specified in other trial drug package inserts/investigator brochures/informed consent forms (whichever is longer), or other conditions deemed unsuitable for enrollment by the researcher.
• •15. Women of childbearing age with a history of preeclampsia: A history/current blood system disease (myelodysplastic syndrome, thalassemia, sickle cell anemia, hemolytic anemia, hemophilia, and/or bleeding disorders).
• •16. Women of childbearing age with a history of preeclampsia: Congestive heart failure (NYHA class II\~IV), myocardial infarction, unstable angina, and/or severe heart disease in the past or present within 6 months before enrollment.
• •17. Women of childbearing age with a history of preeclampsia: Severe cerebrovascular disease within 6 months before enrollment.
• •18. Women of childbearing age with a history of preeclampsia: Evaluation by the investigator at the time of screening for significant lung disease.
• •19. Women of childbearing age with a history of preeclampsia: Severe hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg) or uncontrolled hypertension after antihypertensive medication treatment (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥90 mmHg) or malignant hypertension, hypertensive emergency, hypertensive urgency, etc.
• •20. Women of childbearing age with a history of preeclampsia: Severe or malignant retinopathy. Severe lesions are defined as retinal hemorrhage, microaneurysms, cotton-wool spots, hard exudates, or a combination thereof. Malignant lesions are defined as severe retinopathy combined with optic disc edema.
• •21. Women of childbearing age with a history of preeclampsia: Poorly controlled diabetes, poorly controlled thyroid disease with medication.
• •22. Women of childbearing age with a history of preeclampsia: Severe liver disease or liver dysfunction (ALT or AST \>2×ULN), renal impairment, creatinine (Cr) \>1.5×ULN.