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

NCT06924385 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-04-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Peking University Third Hospital

    collaborator OTHER

  • Xiamen Amoytop Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yuan Wei, Ph.D · Peking University Third Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-06
Primary Completion
2026-01-20
Completion
2026-01-20

Countries

  • China

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06924385 on ClinicalTrials.gov