drugset / Trial / NCT02092077
A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to support selection of an appropriate safe and efficacious dose for study in further development.
Timeline
- Start
- 2014-04-30
- Primary completion
- 2016-04-30
- Completion
- 2016-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ALBUSOMATROPIN | Protein / enzyme biologic | 0.554 mg | — |
| Subject | ALBUSOMATROPIN | Protein / enzyme biologic | 0.924 mg/kg | — |
| Subject | ALBUSOMATROPIN | Protein / enzyme biologic | 1.2 mg/kg | — |
| Comparator | Somatropin | Protein / enzyme biologic | 0.033 mg/kg | — |