drugset / Trial / NCT05627648

Phase 3 Study of KP-100LI in Subjects With Vocal Fold Scar

NCT05627648

Phase 3 Active not recruiting 62 enrolled Kringle Pharma, Inc.
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

EvaluationDrugModalityDoseRoute
Comparator HEPATOPOIETIN-A Protein / enzyme biologic 20 ug Other

Indications

No indication recorded.