Clinical Trial

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

Completed Phase 1
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-04-10; most recent amendment 2026-04-08.
Status change: Recruiting → Completed 2026-04-08
Status change: Not Yet Recruiting → Recruiting 2025-05-28
Trial Details
NCT Number NCT06924385
Lead Sponsor Xiamen Amoytop Biotech Co., Ltd.
Collaborators: Peking University Third Hospital
Conditions Preeclampsia
Enrollment 18 participants
Start Date 2025-04-06
Primary Completion 2026-01-20 (estimated)
Study Completion 2026-01-20 (estimated)
Updated on ClinicalTrials.gov 2026-04-13