Status:
COMPLETED
Safety, Pharmacokinetic, Pharmacodynamic Study of LAPS-IFNa in Healthy Adult Subjects
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief 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 HM10...
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 pharmaco...
Eligibility Criteria
Inclusion
- 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
- Mental Handicap
- Evidence of Clinically Relevant Pathology
- History of Type 1 Diabetes or Thyroid Disease
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01504581
Start Date
March 1 2011
Last Update
February 7 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hanmi clinical
Netherlands, Netherlands