This is a single or up to 2 centers, double-blind, randomized, single-dose, two-way, crossover study comparing the Test (T) and Reference (R) products following subcutaneous administration. Subjects will be randomly assigned to one of two treatments sequences (TR or RT). All subjects will be dosed at the CRO's designated clinical site(s) and the same protocol requirements and procedures will be followed within each group.
The current study design was prepared to assess and compare the PK, PD, safety, tolerability of the Adello biosimilar candidate, TPI-120 and the US-licensed reference product, Neulasta® after administering a single subcutaneous 2 mg dose in healthy adult subjects in a crossover design. The primary PK parameters are AUC0-t, AUC0-inf, and Cmax, and the primary PD parameters are baseline-corrected AUEC0-t and Emax for ANC. This is a single or up to 2 centers, double-blind, randomized, single-dose, two-way, crossover study comparing the Test (T) and Reference (R) products following subcutaneous administration. Subjects will be randomly assigned to one of two treatments sequences (TR or RT). All subjects will be dosed at the CRO's designated clinical site(s) and the same protocol requirements and procedures will be followed within each group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
PEG-rhG-CSF is going to be administered 2 mg/0.2 ml subcutaneously single dose in each study period as per the randomization schedule
PEG-rhG-CSF is going to be administered 2 mg/0.2 ml subcutaneously single dose in each study period as per the randomization schedule
WCCT Global Inc.
Cypress, California, United States
Maximum observed concentration (Cmax)
To evaluate the pharmacokinetics
Time frame: 56 days
Area under the concentration-time curve from time zero to the time of the last non-zero concentration (AUC0-t)
To evaluate the pharmacokinetics
Time frame: 56 days
Area under the concentration-time curve from time zero to infinity (extrapolated AUC0-inf)
To evaluate the pharmacokinetics
Time frame: 56 days
Safety Variable - Tolerability as measured by Injection Site reactions
Tolerability as measured by Injection Site reactions
Time frame: 1, 2, 4, and 24 hours postdose during each study period
Safety Variable - Immunogenicity as measured by presence of Anti Drug Antibodies
Immunogenicity as measured by presence of Anti Drug Antibodies
Time frame: Day 1 of each study period & Day 22 of each study period
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