Safety, Pharmacokinetic, Pharmacodynamic Study of LAPS-IFNa in Healthy Adult Subjects
NCT ID: NCT01504581
Last Updated: 2014-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2011-03-31
Brief Summary
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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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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HM10660A
HM10660A
Single dose of HM10660A 1.5, 2.25, 3.0, or 4.0 ug/kg
Pegasys
Pegasys
Single dose of Pegasys 180ug
HM10660A Placebo
HM10660A placebo
Single dose of HM10660A Placebo
Interventions
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HM10660A
Single dose of HM10660A 1.5, 2.25, 3.0, or 4.0 ug/kg
HM10660A placebo
Single dose of HM10660A Placebo
Pegasys
Single dose of Pegasys 180ug
Eligibility Criteria
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Inclusion Criteria
* 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
* Evidence of Clinically Relevant Pathology
* History of Type 1 Diabetes or Thyroid Disease
18 Years
45 Years
MALE
Yes
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Locations
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Hanmi clinical
Netherlands, , Netherlands
Countries
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Other Identifiers
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11-HM10660A-101
Identifier Type: -
Identifier Source: org_study_id
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