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Phase 3 Study of KP-100LI in Subjects With Vocal Fold Scar
Sponsor: Kringle Pharma, Inc.
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).
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Confirmatory Study For Intracordal Administration Of KP-100LI In Patients With Vocal Fold Scar
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
62
Start Date
2022-12-01
Completion Date
2027-02-28
Last Updated
2025-12-05
Healthy Volunteers
No
Conditions
Interventions
KP-100LI
Intracordal injection, 20 mcg once per week, 3 weeks
Placebo
Intracordal injection, once per week, 3 weeks
Locations (8)
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan
Fukuoka Sanno Hospital
Fukuoka, Fukuoka, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
University Hospital Kyoto Prefectural University of Medicine
Kamigyō-ku, Kyoto, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Kawasaki Medical School Hospital
Kurashiki, Okayama-ken, Japan
Nihon University Hospital
Chiyoda-ku, Tokyo, Japan
Sanno Medical Center
Minato-Ku, Tokyo, Japan