drugset / Trial / NCT01339182
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Pegylated-Somatropin in Healthy Volunteers
Phase 1
Completed
36 enrolled
Xiamen Amoytop Biotech Co., Ltd.
Peking Union Medical College Hospital · collab
RandomizedCrossoverOpen-label
Summary
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.
Timeline
- Start
- 2011-01
- Primary completion
- 2012-08
- Completion
- 2012-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pegylated somatropin | Protein / enzyme biologic | 10 ug/kg | Subcutaneous |
| Subject | Pegylated somatropin | Protein / enzyme biologic | 30 ug/kg | Subcutaneous |
| Subject | Pegylated somatropin | Protein / enzyme biologic | 60 ug/kg | Subcutaneous |
| Subject | Pegylated somatropin | Protein / enzyme biologic | 120 ug/kg | Subcutaneous |
| Subject | Pegylated somatropin | Protein / enzyme biologic | 200 ug/kg | Subcutaneous |
Indications
No indication recorded.