drugset / Trial / NCT01613573
Crossover Study to Assess the Safety and Pharmacokinetic of Pegylated Somatropin(PEG Somatropin) in GHD Children
Phase 1
Completed
12 enrolled
Changchun GeneScience Pharmaceutical Co., Ltd.
Huazhong University of Science and Technology · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2010-03
- Primary completion
- 2010-10
- Completion
- 2010-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pegylated somatropin | Protein / enzyme biologic | 0.2 mg/kg | Subcutaneous |
| Subject | Somatropin | Protein / enzyme biologic | 0.2 mg/kg | — |