Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Pegylated-Somatropin in Healthy Volunteers

Study Overview
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Brief Summary
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This study is aimed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of Pegylated-Somatropin in healthy male volunteers, and collect scientific data for the design and conduct of subsequent studies.

Official Title
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A Randomized, Open-label, Single-dose, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated-Somatropin in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Pegylated-Somatropin
* Drug: YPEG-Somatropin
* Drug: YPEG-Somatropin
* Drug: YPEG-Somatropin
* Drug: YPEG-Somatropin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects Age(yr)between 18 and 45 Body mass index(BMI)between 20 and 28 sign informed consent Exclusion Criteria: Known hypersensitivity to somatropin or any other components of the study drug Organic lesion in heart, liver, kidney or any other major organs History of diabetes mellitus, cancer, autoimmune disease, genetic disease, mental disease Alcoholic, smokers or drug abusers Blood donation, or massive blood loss due to injury or surgery within 3 months Other conditions which in the opinion of the investigator preclude enrollment into the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pegylated-Somatropin, 10mcg/kg<br> | Drug: Pegylated-Somatropin<br>* Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-Somatropin, 10mcg/kg.<br>|
| Experimental: Pegylated-Somatropin, 30mcg/kg<br> | Drug: YPEG-Somatropin<br>* Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 30mcg/kg.<br>|
| Experimental: Pegylated-Somatropin, 60mcg/kg<br> | Drug: YPEG-Somatropin<br>* Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 60mcg/kg.<br>|
| Experimental: Pegylated-Somatropin, 120mcg/kg<br> | Drug: YPEG-Somatropin<br>* Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 120mcg/kg.<br>|
| Experimental: Pegylated-Somatropin, 200mcg/kg<br> | Drug: YPEG-Somatropin<br>* Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 200mcg/kg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the IGF-1 levels for pharmacodynamics study |  | baseline, one week after initiation of the control drug and two weeks after initiation of the study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring the drug levels in blood samples |  | baseline, one week after initiation of the control drug and two weeks after initiation of the study drug | 
| Measurement of IGFBP-3 levels for pharmacodynamic study |  | baseline, one week after initiation of the control drug and two weeks after initiation of the study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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somatropin, PK, PD, male, pharmacokinetics, pharmacodynamics, safety