Safety, Tolerability, and PK/PD of Telpegfilgrastim Injection in Non-pregnant Females of Childbea… (NCT06924385) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability, and PK/PD of Telpegfilgrastim Injection in Non-pregnant Females of Childbearing
China18 participantsStarted 2025-04-06
Plain-language summary
This is an open-label, single-arm, Phase â… a 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.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. 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.
What they're measuring
1
Adverse Event（AE）.
Timeframe: Week1-6.
2
respiration.
Timeframe: Week1-6.
3
body temperature.
Timeframe: Week1-6.
4
Number of participants with clinically significant change from baseline in physical examination.
Timeframe: Week1-6.
5
Number of participants with clinically significant change from baseline in laboratory test.
Timeframe: Week1-6.
6
Electrocardiogram.
Timeframe: Week1-6.
7
Anti-drug antibody.
Timeframe: week1-6.
8
Area under the plasma drug concentration-time curve, AUC 0-t.
Timeframe: Day36.
9
Area Under the Concentration-Time Curve from time 0 to time tau,AUC 0-tau.
✓. 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.
Exclusion criteria
✕. 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.
✕. Healthy, childbearing-age, non-pregnant women: Those with gastrointestinal, liver, kidney, or other known diseases that interfere with drug absorption, distribution, metabolism, or excretion.
✕. 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).
✕. 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;
✕. A history of poorly controlled psychiatric disorders with medication.
✕. 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.
✕. 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.
✕. 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;
Timeframe: Day36.
10
Area under the plasma drug concentration-time curve from time 0 to infinity, AUC 0-∞.