Adult Growth Hormone Deficiency Clinical Trial
Official title:
A Phase II, Randomized, Active Controlled, Open Label Study of Safety and Efficacy of HM10560A a Long-acting rhGH-HMC001 Conjugate in Treatment of Subjects Suffering From Adult Growth Hormone Deficiency (AGHD)
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)
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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