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OpenTrials
Completed

NCT Number: NCT01504581

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

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Hanmi clinical

Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HM10660A

Biological

Single dose of HM10660A 1.5, 2.25, 3.0, or 4.0 ug/kg

HM10660A placebo

Biological

Single dose of HM10660A Placebo

Pegasys

Biological

Single dose of Pegasys 180ug

Primary outcomes

  1. Number of participants with AE occurrence, clinically significant clinical lab, vital sign, and/or ECG change

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
First posted
Jan 5, 2012
Registry last updated
Feb 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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