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

NCT07738991 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2026-07-31

No results posted yet for this study

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

Conditions

  • Healthy Participants

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

Sponsors & Collaborators

  • Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-03
Primary Completion
2026-11-09
Completion
2027-04-12
FDA Drug
Yes

Countries

  • China

Study Locations

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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 NCT07738991 on ClinicalTrials.gov