drugset / Trial / NCT05838885
A Trial of YPEG-rhGH in Children With Short Stature
RandomizedParallel-groupOpen-labelTreatment
Summary
To explore the dose-response relationship between pharmacokinetics and pharmacodynamics of Y- Shaped Pegylated growth hormone injection (YPEG-GH) in children with short stature (idiopathic short stature (ISS), small for gestational age (SGA), Turner syndrome (TS)). To evaluate its tolerability, safety and efficacy and to provide evidence for dose selection and titration for future clinical development and clinical application in these population.
Timeline
- Start
- 2022-02-15
- Primary completion
- 2023-10-23
- Completion
- 2023-12-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Somatropin | Protein / enzyme biologic | 245 ug/kg | Subcutaneous |
| Comparator | Somatropin | Protein / enzyme biologic | 470 ug/kg | Subcutaneous |
| Subject | YPEG-rhGH | Protein / enzyme biologic | 140 ug/kg | Subcutaneous |
| Subject | YPEG-rhGH | Protein / enzyme biologic | 280 ug/kg | Subcutaneous |