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

Launched by XIAMEN AMOYTOP BIOTECH CO., LTD. · Mar 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called telpegfilgrastim to see if it is safe and well-tolerated in healthy women who are not pregnant and are between the ages of 18 and 45. The trial aims to understand how the drug works in the body after a single dose. Researchers will enroll 18 women, who will receive different doses of the medication and will be monitored closely for any side effects and changes in their health for up to 21 days after taking the drug.

To participate, women need to meet certain criteria, such as being healthy, having a body mass index within a specific range, and agreeing to use reliable contraception during the study. Participants will go through a series of health checks before starting the trial, and they must be comfortable with providing blood samples. It’s important to note that women with certain medical conditions, recent infections, or those taking specific medications may not be eligible. Overall, this study is crucial for understanding the potential of telpegfilgrastim in addressing conditions like preeclampsia, which affects pregnant women.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. The participants is able to understand and comply with the contents, requirements, and restrictions of the protocol, complete the study as required by the protocol, and is fully aware of the possible adverse reactions, voluntarily signing the informed consent form before enrolling the trial.
• • 2. Female, aged between 18 and 45 years old (inclusive of 18 and 45 years).
• • 3. Body Mass Index (BMI) ≥ 18.5 and \< 28.0 kg/m², weight ≥ 45 kg.
• • 4. At the screening visit and before the first dose on Day 1, 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), laboratory tests (blood routine, blood biochemistry, coagulation function, thyroid function (FT3, FT4, TSH), urinalysis, etc.), and auxiliary examinations (anteroposterior chest X-ray, 12-lead ECG, ultrasonography) with all indices normal or abnormal but without clinical significance.
• • 5. Willing to participate in the planned pharmacokinetic (PK) blood sampling studies and able to comply with the medication and blood sample collection procedures.
• 6. Negative blood pregnancy test within 24 hours before the first dose, and the participant must agree to use effective contraceptive measures during the study period and for 6 months after medication, agreeing to use at least one of the following contraceptive methods:
• • Condoms; Subcutaneous contraceptive implant; Intrauterine device or intrauterine system; High-efficiency oral contraceptives, combined or progestin-only; Injectable progestin; Contraceptive vaginal ring; Transdermal contraceptive patch.
• Exclusion Criteria:
• • 1. Significant prolongation of QT/QTc interval during the screening period and baseline (e.g., repeatedly confirmed QTcF interval \> 450 ms);
• • 2. Organic lesions in vital organs such as the heart, liver, kidneys, brain, and lungs; a clear history of diseases or other significant conditions in the central nervous system, cardiovascular system, cerebrovascular, hematologic, urinary, digestive, respiratory, metabolic, and musculoskeletal systems; a history of autoimmune diseases; a history of endocrine disorders, such as thyroid dysfunction;
• • 3. Diseases of the gastrointestinal tract, liver, kidneys, or other conditions known to interfere with drug absorption, distribution, metabolism, or excretion;
• • 4. 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);
• • 5. Other risk factors for torsades de pointes ventricular tachycardia (TdP) in the medical history (such as heart failure, hypokalemia, family history of long QT syndrome);
• • 6. 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;
• • 7. History of poorly controlled psychiatric illness with medication;
• • 8. Current or history of severe or persistent infection within the past 3 months (requiring hospitalization or opportunistic infection); 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;
• • 9. 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 Escherichia coli;
• • 10. 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;
• • 11. Use of any prescription or over-the-counter medications (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 investigator and the sponsor agree that it has no impact on the clinical study;
• • 12. 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.);
• • 13. Concomitant use with drugs that prolong the QT/QTc interval;
• • 14. Vaccination with live or attenuated vaccines within 3 months before the start of the trial;
• • 15. 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);
• • 16. Smoking (or use of tobacco-containing products) in the past 3 months, or unwillingness to refrain from smoking during the study period;
• • 17. Participation in a clinical drug trial within the past 3 months or during the time frame equivalent to 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 inclusion by the investigator.