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

Kringle Pharma

Status and phase: Enrolling; Phase 3

Conditions: Vocal Fold Scar

Treatments: Drug: Placebo; Drug: KP-100LI

Study type: Interventional

Funder types: Industry

Identifiers

NCT05627648

KP-100-FD001

Details and patient eligibility

About

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).

Enrollment: 62 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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62 participants in 2 patient groups, including a placebo group

KP-100LI

Active Comparator group

Description:

Intracordal injection, 20 mcg once per week, 3 weeks

Treatment:

Drug: KP-100LI

Placebo

Placebo Comparator group

Description:

Intracordal injection, once per week, 3 weeks

Treatment:

Drug: Placebo