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

NCT01504581 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-02-07

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-09-30

Countries

  • Netherlands

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01504581 on ClinicalTrials.gov