NCT01504581

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	HM10660A	Single dose of HM10660A 1.5, 2.25, 3.0, or 4.0 ug/kg
BIOLOGICAL	HM10660A placebo	Single dose of HM10660A Placebo
BIOLOGICAL	Pegasys	Single dose of Pegasys 180ug

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-09-01
• First posted: 2012-01-05
• Last updated: 2014-02-07

Locations

1 site across 1 country: Netherlands