NCT06893796

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

A Phase Ia Clinical Trial Aimed at Evaluating the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Characteristics of Single Dose of Telpegfilgrastim Injection in Healthy Premenopausal Non-pregnant Women

• 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, Phase Ia clinical study to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of single dose of telpegfilgrastim injection in healthy premenopausal non-pregnant women. It plans to enroll 18 healthy premenopausal non-pregnant female.,). Participants will be enrolled sequentially according to their screening numbers in the following three dose groups:0.25mg, 0.5mg, and 1mg, with 6 participants in each dose group. Each participant will undergo a screening period (-2 weeks to -2 days), a baseline phase (D-1, the day before the first dose), and a post-dosing observation period (Day 1 to Day 21), and adverse event, vital signs, physical examination, laboratory tests,and PK\&PD will be calculated.

Conditions

• Preeclampsia

Interventions

Type	Name	Description
DRUG	Telpegfilgrastim Injection	Telpegfilgrastim Injection,0.25mg, s.c.,day 1 single dose .
DRUG	Telpegfilgrastim Injection	Telpegfilgrastim Injection,0.5mg, s.c.,day 1 single dose .
DRUG	Telpegfilgrastim Injection	Telpegfilgrastim Injection,1mg, s.c.,day 1 single dose .

Timeline

• Start date: 2025-03-26
• Primary completion: 2025-05-08
• Completion: 2025-05-08
• First posted: 2025-03-25
• Last updated: 2025-05-30

Locations

1 site across 1 country: China