RecruitingPhase 1NCT06924385

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

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

Sponsor

Xiamen Amoytop Biotech Co., Ltd.

Enrollment

30 participants

Start Date

Apr 6, 2025

Study Type

INTERVENTIONAL

Conditions

Preeclampsia

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing how the body processes a drug called telpegfilgrastim — a medication that stimulates white blood cell production — in healthy women of childbearing age. The focus is on safety and how the body absorbs and eliminates the drug. **You may be eligible if...** - You are a woman between 18 and 45 years old - You are healthy and not currently pregnant - Your BMI is between 18.5 and 28, and you weigh at least 45 kg - Your heart rate, blood pressure, and general health checks are within normal ranges - You are willing to use effective contraception during the study **You may NOT be eligible if...** - You are pregnant, breastfeeding, or planning to become pregnant during the study - You have a known allergy to similar medications (e.g., G-CSF drugs) - You have significant health conditions (heart, liver, kidney, blood disorders) - You have recently taken other medications that could interfere with the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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