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

NCT06893796 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-05-30

No results posted yet for this study

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

Interventions

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 .

Sponsors & Collaborators

  • Peking University Third Hospital

    collaborator OTHER

  • Xiamen Amoytop Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Dongyang Liu, 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
2025-03-26
Primary Completion
2025-05-08
Completion
2025-05-08

Countries

  • China

Study Locations

More Related Trials

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 NCT06893796 on ClinicalTrials.gov