A Phase Ⅰa Clinical Trial Designed to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Properties of Multiple Doses of Telpegfilgrastim Injection in Non-pregnant Females of Childbearing
This is an open-label, single-arm, Phase Ⅰa clinical study designed to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of multiple doses of Telpegfilgrastim Injection in non-pregnant women of childbearing. It contains two cohorts: Cohort 1, healthy childbearing-age non-pregnant participants, and Cohort 2, childbearing-age non-pregnant participants with a history of preeclampsia, totaling 30 non-pregnant women of childbearing age will be enrolled. Each participant in Cohort 2 will go through a screening period, a baseline phase (the day before the first dose), a treatment period, and a follow-up period after dosing.
• Participants are able to understand and comply with the contents, requirements, and restrictions of the protocol, complete the study as required by the protocol, and are fully aware of the possible adverse reactions, and voluntarily sign the informed consent form before the trial.
• Female, aged between 18 and 45 years old (inclusive of 18 and 45 years old).
• Body Mass Index (BMI) ≥18.5 and \<28.0 kg/m\^2, weight ≥45 kg.
• Healthy, childbearing-age, non-pregnant women: At the screening visit and before the first dose administration, a comprehensive physical examination is conducted, including general physical examination, vital signs (pulse between 50 and 100 bpm at rest, systolic blood pressure between 90 and 139 mmHg, diastolic blood pressure between 50 and 89 mmHg, inclusive of the critical values), as well as laboratory tests \[blood routine, blood biochemistry, coagulation function, thyroid function (FT3, FT4, TSH), urine routine, etc.\] and auxiliary examinations (anteroposterior chest X-ray, 12-lead ECG, ultrasonography) showing all parameters normal or abnormal but without clinical significance.
• Willing to participate in the planned PK blood sampling studies and able to comply with the medication and blood sample collection procedures.
• Negative blood pregnancy test within 24 hours before the first dose administration, and the participant must agree to use effective contraceptive measures during the study period and for 6 months after medication. The participant must agree to use at least one of the following contraceptive methods: condom; subcutaneous contraceptive implant; intrauterine device or intrauterine system; high-efficiency oral contraceptives, with or without progestin; injectable progestin; contraceptive vaginal ring; transdermal contraceptive patch.
• Women of childbearing age with a history of preeclampsia: A documented history of pulmonary embolism (PE), requiring confirmation of the diagnosis through prior hospitalization medical records.