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

NCT05627648 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-12-05

No results posted yet for this 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).

Conditions

  • Vocal Fold Scar

Interventions

DRUG

KP-100LI

Intracordal injection, 20 mcg once per week, 3 weeks

DRUG

Placebo

Intracordal injection, once per week, 3 weeks

Sponsors & Collaborators

  • Kringle Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Daichika Hayata · Kringle Pharma, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2026-08-31
Completion
2027-02-28

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05627648 on ClinicalTrials.gov