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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: HM10660A; Biological: Pegasys; Biological: HM10660A placebo

• Registration Number: NCT01504581
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief 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

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-09
• Study First Submitted: 2011-12-27
• Study First Submitted QC: 2012-01-03
• Study First Posted: 2012-01-05
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-06
• Last Update Posted: 2014-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HM10660A	HM10660A	-
Pegasys	Pegasys	-
HM10660A Placebo	HM10660A placebo	-

Primary Outcome Measures

Name	Time	Method
Number of participants with AE occurrence, clinically significant clinical lab, vital sign, and/or ECG change	43 days	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.

Trial Locations

Locations (1)

Hanmi clinical; 🇳🇱 Netherlands, Netherlands