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
Participants will be admitted to the clinical research unit (CRU) on Day -1. Eligible participants will be randomized (1:1) on Day -1 to 1 of 2 treatment sequences. Participants will then receive a single 6 mg SC dose during Treatment Period 1 of either NKF-PEG, or US-Neulasta, according to the randomization schedule. Participants will be discharged from the CRU on Day 13 and will return to the CRU on Day 16 for PK/PD analysis and for safety assessments. Following the washout period of 6 weeks, the same schedule will be followed for Treatment Period 2, where participants will receive a single 6 mg SC dose of the final product according to their treatment sequence, then discharge from the CRU on Day 13 of Treatment Period 2 and will return for ambulatory visits on Day 16 of Treatment Period 2 and Safety Visit (Day 84).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
202
NKF-PEG administered as a single 6 mg SC dose in the periumbilical area
US-Neulasta administered as a single 6 mg SC dose in the periumbilical area
Ethics Committee of Hopeshine-Minsheng Hospital of Xinzheng, Zhengzhou,
Zhengzhou, China
RECRUITINGAUC0-t
Area under the concentration-time curve from time 0 to the last quantifiable concentration
Time frame: 0 to 360 hours
Cmax
Maximum observed serum concentration
Time frame: 0 to 360 hours
AUEC0- t for ANC
Area under the effect curve for ANC
Time frame: 0 to 360 hours
Emax of ANC
Maximum response (Emax) of ANC
Time frame: 0 to 360 hours
AUC0-inf
Area under the concentration-time curve from time 0 extrapolated to infinity
Time frame: 0 to 360 hours
Tmax
Time to Cmax
Time frame: 0 to 360 hours
T1/2
Terminal half-life
Time frame: 0 to 360 hours
Tmax of ANC
Time to Emax of ANC
Time frame: 0 to 360 hours
Tmax of CD34+ cell count
Time to Emax of CD34+ cell count
Time frame: 0 to 360 hours
AUEC0-t of CD34+ cell count
Area under the effect curve of CD34+ cell count
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Time frame: 0 to 360 hours
Emax of CD34+ cell count
Maximum response (Emax) of CD34+ cell count
Time frame: 0 to 360 hours
The proportion of participants with treatment-induced anti-pegfilgrastim antibodies at any time during the study
Time frame: 0-84 days
The proportion of participants with treatment-induced anti-filgrastim antibodies at any time during the study
Time frame: 0-84 days
The proportion of participants with treatment-induced anti-PEG antibodies at any time during the study
Time frame: 0-84 days
The proportion of participants with post dose positive neutralizing antibody result of pegfilgrastim at any time during the study
Time frame: 0-84 days
Adverse event (AE) assessments (including injection site reactions)
Frequency of Adverse event (AE) (including injection site reactions)
Time frame: 0-84 days