The purpose of this study is to assess the safety, tolerability and Pharmacokinetic/ Pharmacodynamic (PK/PD) profile of three doses of HM10560A on an every week (EW) regime and one dose on every other week (EOW) regime administered for a period of 24 weeks initial study.
* To select the optimal dose and dosing regimen of HM10560A for the subsequent phase III study on the basis of the safety and PK/PD profile after 24 weeks of treatment * To assess the long term safety of HM10560A when administered in optimal dose range and dose frequency for additional 48 weeks (followed with 2 weeks safety follow up)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Once weekly HM10560A
Once daily Genotropin
Hanmi Pharmaceutical
Budapest, Hungary
Change of IGF-I levels in function of time, and dose strengths
The results from each month minus baseline
Time frame: baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months
IGF-I SDS; changes to baseline in IGF-I SDS
The results from each month minus baseline
Time frame: baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months
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