Clinical Trial: Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1, Open-Label, Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of Pegylated Somatropin(PEG Somatropin) in GHD Children

Brief Summary: The purpose of the phase 1 study is to assess the safety and pharmacokinetics of PEG somatropin, which administered once per week, compared with the daily used somatropin, and to evaluate the safety and possibility to replace daily used somatropin.

Detailed Summary:
Sponsor: GeneScience Pharmaceuticals Co., Ltd.

Current Primary Outcome: pharmacokinetics parameter [ Time Frame: Somatropin AQ: predose(0),1,2,3,4,6,8,10,12,16,20,24 hours post-dose. PEG somatropin: predose (0),2,4,8,12,18,24,36,48,72,96,120,144,168 hours post-dose ]

Cmax, AUC during the time interval for the first dose and last dose, Half-Life(t1/2), Apparent body clearance(CL), Mean residence time(MRT),steady-state volume of distribution(Vss)


Original Primary Outcome: pharmacokinetics parameter [ Time Frame: predose,1,2,3,4,6,8,10,12,16,20,24 hours post-dose ]

Cmax, AUC during the time interval for the frist dose and last dose, Half-Life(t1/2), Apparent body clearance(CL), Mean residence time(MRT),steady-state volume of distribution(Vss)


Current Secondary Outcome: IGF-1, IGFBP-3 [ Time Frame: Day I to Day 7 in each treatment period (33 time points) for daily used somatropin, Day I to Day 42 in each treatment period (35 time points) for PEG somatropin ]

Original Secondary Outcome: Same as current

Information By: GeneScience Pharmaceuticals Co., Ltd.

Dates:
Date Received: June 1, 2012
Date Started: March 2010
Date Completion:
Last Updated: June 13, 2012
Last Verified: October 2010