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Clinical Trials in Japan / NCT05627648
Active, not recruiting Phase 3

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

NCT05627648 · tracked via the Priya Life Science Japan tracker
Sponsor
Kringle Pharma, Inc
Phase
Phase 3
Started
2022-12-01
Last updated
2026-07-06

Condition(s) studied

Vocal Fold Scar

Investigational drug(s) / intervention(s)

KP-100LIPlacebo

KP-100LI: Intracordal injection, 20 mcg once per week, 3 weeks

Placebo: Intracordal injection, once per week, 3 weeks

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. 18 years to 75 years 2. Presence of bilateral vocal fold scar or sulcus diagnosed 3. No other vocal lesion or vocal movement disorder 4. Voice Handicap Index-10 (VHI-10) score of 11 or higher 5. No laryngoplasty, collagen or lipid infusion to vocal cord, removal scar, fascial graft, or administration of steroid or hyaluronic acid to vocal cord Exclusion Criteria: 1. No movement disorders of the vocal fold including paralysis 2. Airway disease caused by burn 3. History of malignant tumor 4. History of allergy to local anesthesia agent 5. With impaired coagulation-fibrinolysis, or taking anticoagulant or antiplatelet drugs 6. Serious concomitant disease 7. Pregnant (including suspected), nursing, wishing to become pregnant, or unable to prevent conception during the trial period using contraceptive methods

Primary outcome measure(s)

  • Improvement rate in Voice Handicap Index-10 (VHI-10) score at 24 weeks of the observational period — 24 weeks

Trial sites (8)

FacilityCityRegionStatus
Fujita Health University Hospital Toyoake Aichi-ken
Fukuoka Sanno Hospital Fukuoka Fukuoka
Kurume University Hospital Kurume Fukuoka
University Hospital Kyoto Prefectural University of Medicine Kamigyō-ku Kyoto
Tohoku University Hospital Sendai Miyagi
Kawasaki Medical School Hospital Kurashiki Okayama-ken
Nihon University Hospital Chiyoda-ku Tokyo
Sanno Medical Center Minato-Ku Tokyo

More Kringle Pharma, Inc. trials in Japan

Additional Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05627648 on ClinicalTrials.gov ↗ ← All trials in Japan