NCT06924385

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Xiamen Amoytop Biotech Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Preeclampsia

Interventions

Type	Name	Description
DRUG	Telpegfilgrastim Injection	Telpegfilgrastim will be administered as subcutaneous (SC) injection.
DRUG	Telpegfilgrastim Injection	Telpegfilgrastim will be administered as subcutaneous (SC) injection.
DRUG	Telpegfilgrastim Injection	Telpegfilgrastim will be administered as subcutaneous (SC) injection.
DRUG	Telpegfilgrastim Injection	Telpegfilgrastim will be administered as subcutaneous (SC) injection.
DRUG	Telpegfilgrastim Injection	Telpegfilgrastim will be administered as subcutaneous (SC) injection.

Timeline

• Start date: 2025-04-06
• Primary completion: 2026-01-20
• Completion: 2026-01-20
• First posted: 2025-04-11
• Last updated: 2026-04-13

Locations

1 site across 1 country: China