NCT01613573

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 4 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	somatropin AQ	somatropin injection 0.2mg/kg/w once per day, inject for 7 continuous days 4 weeks for cleaning period
DRUG	pegylated somatropin	Pegylated somatropin 0.2mg/kg/w once per week, for continuous 6 weeks Subcutaneous injection

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-10-01
• Completion: 2010-11-01
• First posted: 2012-06-07
• Last updated: 2012-06-14