The purpose of this study is to compare the safety, tolerability, and blood levels of two interferon beta-1b products, Betaferon and PF530, in healthy volunteers.
This is a double-blind, randomised, two-treatment cross-over study in healthy adult subjects to compare the safety, tolerability, pharmacokinetics and pharmacodynamics of PF530 and Betaferon. Half of the subjects will be randomised to receive PF530 first and Betaferon second, and the other half will be randomised to receive the drugs in reverse sequence. Each study participant will complete two 7-day study periods (Period 1 and Period 2), separated by a 14-day washout period. In Part I of the study, 12 subjects will be enrolled for an initial assessment. In Part II, up to 36 additional subjects may be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12
Single subcutaneous administration
CMAX
Adelaide, South Australia, Australia
Adverse event (AE) and serious adverse event (SAE) incidence
Time frame: 28 Days
Serum area-under-the-curve (AUC) of PF530 and Betaferon
Time frame: 72 hours
Serum maximum concentration (Tmax) of PF530 and Betaferon
Time frame: 72 hours
Serum half-life (t1/2) of PF530 and Betaferon
Time frame: 72 hours
Serum neopterin
Time frame: 168 hours
Serum myxovirus resistance protein A
Time frame: 168 hours
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