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: February 6, 2014
Last verified: February 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Netherlands
Hanmi clinical
Netherlands, Netherlands
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
  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: February 6, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

ClinicalTrials.gov processed this record on October 23, 2014