drugset / Trial / NCT04775706
Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a randomized, double-blind, placebo-controlled, proof-of-concept (PoC), Phase 2 study to assess the safety, PK, and PD of SC administration of HM15912(sonefpeglutide) in adult subjects with SBS-associated intestinal failure (SBS-IF).
Timeline
- Start
- 2022-03-03
- Primary completion
- 2027-12
- Completion
- 2028-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sonefpeglutide | Unknown | 0.5 mg/kg | Subcutaneous |
| Subject | Sonefpeglutide | Unknown | 1 mg/kg | Subcutaneous |
| Subject | Sonefpeglutide | Unknown | 1.5 mg/kg | Subcutaneous |