NCT01822340

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 23 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

* 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)

Conditions

• Adult Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	HM10560A	Once weekly HM10560A
DRUG	Genotropin	Once daily Genotropin

Timeline

• Start date: 2011-10-01
• Primary completion: 2015-06-01
• Completion: 2016-02-01
• First posted: 2013-04-02
• Last updated: 2016-02-19

Locations

1 site across 1 country: Hungary