drugset / Trial / NCT07260500
A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and Pharmacokinetics
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will take place at multiple sites and is divided into three phases:an initial 4-week getting-to-know-you phase,a 26-week main phase where participants receive medication,and a 4-week follow-up phase.Participants will be divided into three groups:two will receive different doses of PEG-rhGH Injection,and the third will receive hGH Injection.The goal is to determine which medication works best.
Timeline
- Start
- 2025-11-11
- Primary completion
- 2026-12-23
- Completion
- 2027-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PEG-rhGH | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | hGH | Protein / enzyme biologic | — | Subcutaneous |