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RECRUITING
NCT07738991
PHASE1

A Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of NKF-PEG, and US-Neulasta in Healthy Adult Male Volunteers

Sponsor: Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

A Single Center, Single-Dose, Double-Blind, Randomized, Two-Period, Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-PEG, and US-Neulasta®, and to Evaluate Safety in Healthy Adult Male Volunteers

Official title: A Single Center, Single-Dose, Double-Blind, Randomized, Two-Period, Crossover Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-PEG, and US-Neulasta®, and to Evaluate Safety in Healthy Adult Male Volunteers

Key Details

Gender

MALE

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

202

Start Date

2026-07-03

Completion Date

2027-04-12

Last Updated

2026-07-31

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

NKF-PEG

NKF-PEG administered as a single 6 mg SC dose in the periumbilical area

BIOLOGICAL

US-Neulasta

US-Neulasta administered as a single 6 mg SC dose in the periumbilical area

Locations (1)

Ethics Committee of Hopeshine-Minsheng Hospital of Xinzheng, Zhengzhou,

Zhengzhou, China