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RecruitingPhase 1NCT07738991

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

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

Sponsor

Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.

Enrollment

202 participants

Start Date

Jul 3, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy Participants

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

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called NKF-PEG and a biological treatment called US-Neulasta for people with healthy participants. The study is currently recruiting participants at 1 location. People eligible for this study include men aged 18 Years to 55 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALNKF-PEG

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

BIOLOGICALUS-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

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NCT07738991

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