Clinical Trial

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

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Record status
This record was last updated July 6, 2026 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-11-16; most recent amendment 2026-07-01.
Status change: Recruiting → Active, Not Recruiting 2026-07-01
Status change: Not Yet Recruiting → Recruiting 2023-11-09
Trial Details
NCT Number NCT05627648
Lead Sponsor Kringle Pharma, Inc.
Conditions Vocal Fold Scar
Enrollment 62 participants
Start Date 2022-12-01
Primary Completion 2026-07-31 (estimated)
Study Completion 2027-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-07-06