Study design: This is a randomized, double-blind, placebo- and active-controlled, single-dose study in 4 groups of 12 healthy male subjects each. In each group, 8 subjects will receive a dose of HM10660A, 2 subjects will receive a single dose of placebo and 2 subjects will receive a single dose of a currently marketed PEG-interferon.
Primary objective: to study the safety and tolerability of HM10660A, including immunogenicity, as compared to PEG-interferon alpha-2a Secondary objective: to study the pharmacokinetics and pharmacodynamics of HM10660A as compared to PEG-interferon alpha-2a
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Single dose of HM10660A 1.5, 2.25, 3.0, or 4.0 ug/kg
Single dose of HM10660A Placebo
Single dose of Pegasys 180ug
Hanmi clinical
Netherlands, Netherlands
Number of participants with AE occurrence, clinically significant clinical lab, vital sign, and/or ECG change
Number of participants with AE occurrence, clinically significant clinical lab, vital sign, and/or ECG change among HM10660A receivers will be assessed. It can be compared to those numbers in Active comparator group.
Time frame: 43 days
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