This is an open-label, randomized, multi-center, single dose, two-period, two-sequence crossover study to investigate the bioequivalence of PEG-IFN alfa-2a BA-free formulation versus the reference market formulation (PEG-IFN alfa-2a \[Pegasys®\]) following subcutaneous administration via prefilled syringe in healthy Chinese participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
277
Participants will receive single injection of 180 micrograms (mcg) of PEG-IFN alfa-2a BA-free formulation, subcutaneously via prefilled syringe in either period 1 and 2 (each period having 35 days).
Participants will receive single injection of 180 mcg of PEG-IFN alfa-2a market formulation, subcutaneously via prefilled syringe in either period 1 and 2 (each period having 35 days).
CMAX A division of IDT Australia Limited
Adelaide, South Australia, Australia
The University of Hong Kong; Pharmacy Clinical Trials
Hong Kong, Hong Kong
The Chinese University of Hong Kong; Emergency Medicine
Shatin, Hong Kong
Maximum Observed Concentration (Cmax) for PEG-IFN alfa-2a
Time frame: Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose
Area Under the Concentration-Time Curve (AUC) for PEG-IFN alfa-2a From Time Zero to 816 hours (AUC0-816h)
Time frame: Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose
Area Under the Concentration-Time Curve for PEG-IFN alfa-2a From Time Zero Extrapolated to Infinity (AUC0-inf)
Time frame: Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose
Time to Reach Cmax (tmax) for PEG-IFN alfa-2a
Time frame: Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose
Terminal Half-Life (t1/2) for PEG-IFN alfa-2a
Time frame: Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose
Percentage of Participants With Adverse Events
Time frame: Baseline up to 35 days post last dose of PEG-IFN alfa-2a (maximum up to 17.5 weeks)
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Christchurch Clinical Studies Trust
Christchurch, New Zealand
Auckland Clinical Studies Limited
Grafton, New Zealand
SingHealth Investigational Medicine Unit; Haematology
Singapore, Singapore
Changi General Hospital- Parent; Department of Rheumatology
Singapore, Singapore
China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H
Taichung, Taiwan
Taipei Medical University Hospital; Clinical Research Center
Taipei, Taiwan