Safety, Pharmacokinetic, Pharmacodynamic Study of LAPS-IFNa in Healthy Adult Subjects

A Randomized, Double-Blind, Placebo- And Active-Controlled Study Of The Pharmacokinetics, Pharmacodynamics And Safety Of Single Ascending Doses Of HM10660A (LAPS-INTERFERON ALPHA-2B) In Healthy Male Subjects

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

Inclusion Criteria:

• Age: 18 - 45 Years, Inclusive
• BMI: 18.0 - 28.0 kg/m2
• Are Non-smokers or Smoker of Fewer Than 5 Cigarettes Per Day as Determined by History

Exclusion Criteria:

• Mental Handicap
• Evidence of Clinically Relevant Pathology
• History of Type 1 Diabetes or Thyroid Disease