drugset / Trial / NCT05627648
Phase 3 Study of KP-100LI in Subjects With Vocal Fold Scar
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to confirm the efficacy and safety of KP-100LI, a intracordal formulation containing recombinant human dHGF as the active pharmaceutical ingredient, for voice function improvement therapy in patients with vocal fold scar (including vocal fold sulcus).
Timeline
- Start
- 2022-12-01
- Primary completion
- 2026-07-31
- Completion
- 2027-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | HEPATOPOIETIN-A | Protein / enzyme biologic | 20 ug | Other |
Indications
No indication recorded.