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

Study Overview
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Brief Summary
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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
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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)

Official Title
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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)

Conditions
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Adult Growth Hormone Deficiency

Intervention / Treatment
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* Drug: HM10560A
* Drug: Genotropin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: GHDA subjects, males and females, of age between 23 and 60 years as defined in the Consensus Guidelines for the Diagnosis and Treatment of Adults with GH Deficiency II (2007) as well as American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for Growth Hormone Use in Growth Hormone-Deficient Adults and Transition Patients (2009); r-hGHdrug naïve or any registered or investigational r-hGH replacement therapy was not given for more than 6 months before the screening. Body Mass Index (BMI, kg/m2) of both male and female patients must be between 22.0 to 35.0 kg/m2. Female patients must have a negative serum pregnancy test at inclusion. Confirmed to be negative for anti r-hGH antibodies at the time of screening. Willing and able to provide written informed consent prior to performing any study procedures. Exclusion Criteria: Patients with childhood onset of GHD treated with r-hGH before the age of 18. Current antitumor therapy. Subjects presenting with any clinically significant ECG abnormality. Evidence of intracranial hypertension. Significant hepatic dysfunction (persistent elevation of alanine transaminase [ALT] or aspartate transaminase [AST] >1.5 x upper limit of normal). Pregnancy and breastfeeding;

Ages Eligible for Study
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Minimum Age: 23 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Once weekly HM10560A | Drug: HM10560A<br>* Once weekly HM10560A<br>* Other names: LAPS-rhGH;|
| Experimental: Cohort 2<br>Once weekly HM10560A | Drug: HM10560A<br>* Once weekly HM10560A<br>* Other names: LAPS-rhGH;|
| Experimental: Cohort 3<br>Once weekly HM10560A | Drug: HM10560A<br>* Once weekly HM10560A<br>* Other names: LAPS-rhGH;|
| Experimental: Cohort 4<br>Biweekly HM10560A | Drug: HM10560A<br>* Once weekly HM10560A<br>* Other names: LAPS-rhGH;|
| Active Comparator: Cohort 5<br>Once daily Genotropin | Drug: Genotropin<br>* Once daily Genotropin<br>* Other names: Genotropin 5.3mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of IGF-I levels in function of time, and dose strengths | The results from each month minus baseline | baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGF-I SDS; changes to baseline in IGF-I SDS | The results from each month minus baseline | baseline, 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AGHD