drugset / Trial / NCT01822340

Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients

NCT01822340

Phase 2 Completed 72 enrolled Hanmi Pharmaceutical Company Limited
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2011-10
Primary completion
2015-06
Completion
2016-02

Drugs

EvaluationDrugModalityDoseRoute
Subject HM10560A Protein / enzyme biologic
Comparator Somatropin Protein / enzyme biologic

Indications