Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06924385
PHASE1

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

Sponsor: Xiamen Amoytop Biotech Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-04-06

Completion Date

2025-12

Last Updated

2025-05-30

Healthy Volunteers

Yes

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.

Locations (1)

Peking University Third Hospital

Beijin, Beijing Municipality, China