Trials / Recruiting
RecruitingNCT05627648
Phase 3 Study of KP-100LI in Subjects With Vocal Fold Scar
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Confirmatory Study For Intracordal Administration Of KP-100LI In Patients With Vocal Fold Scar
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- Sponsor
- Kringle Pharma, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KP-100LI | Intracordal injection, 20 mcg once per week, 3 weeks |
| DRUG | Placebo | Intracordal injection, once per week, 3 weeks |
Timeline
- Start date
- 2022-12-01
- Primary completion
- 2026-08-31
- Completion
- 2027-02-28
- First posted
- 2022-11-25
- Last updated
- 2025-12-05
Locations
8 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT05627648. Inclusion in this directory is not an endorsement.