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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01504581
First received: December 27, 2011
Last updated: January 5, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Biological: HM10660A
Biological: HM10660A placebo
Biological: Pegasys
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • Number of participants with AE occurrence, clinically significant clinical lab, vital sign, and/or ECG change [ Time Frame: 43 days ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 48
Study Start Date: March 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HM10660A Biological: HM10660A
Single dose of HM10660A 1.5, 2.25, 3.0, or 4.0 ug/kg
Active Comparator: Pegasys Biological: Pegasys
Single dose of Pegasys 180ug
Placebo Comparator: HM10660A Placebo Biological: HM10660A placebo
Single dose of HM10660A Placebo

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504581

Locations
Netherlands
PRA
Groningen, Netherlands
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Principal Investigator: Thihs Iersel,van, M.D PRA International
  More Information

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01504581     History of Changes
Other Study ID Numbers: 11-HM10660A-101
Study First Received: December 27, 2011
Last Updated: January 5, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013