Phase 3 Study of KP-100LI in Subjects With Vocal Fold Scar | NCT05627648

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

NCT05627648

Sponsor

Kringle Pharma, Inc.

Status

Active, not recruiting

Last Update Posted

Jul 6, 2026Actual

Enrollment

62Estimated

Phase

Phase 3

Conditions

Vocal Fold Scar

Interventions

KP-100LI
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2022Actual

Primary Completion Date

Jul 31, 2026Estimated

Completion Date

Feb 28, 2027Estimated

First Submitted Date

Nov 16, 2022

First Submission Date that Met QC Criteria

Nov 16, 2022

First Posted Date

Nov 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2026

Last Update Posted Date

Jul 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
KP-100LI	Active Comparator	Intracordal injection, 20 mcg once per week, 3 weeks	Drug: KP-100LI
Placebo	Placebo Comparator	Intracordal injection, once per week, 3 weeks	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KP-100LI	Drug	Intracordal injection, 20 mcg once per week, 3 weeks	KP-100LI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement rate in Voice Handicap Index-10 (VHI-10) score at 24 weeks of the observational period		24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Improvement rate in VHI-10 score from just before the first administration ("baseline" at 0 week) to 4, 8, and 12 weeks of the observational period		up to 12 weeks
Changes in VHI-10 score from baseline to 4, 8, 12, and 24 weeks of the observational period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years to 75 years
Presence of bilateral vocal fold scar or sulcus diagnosed
No other vocal lesion or vocal movement disorder
Voice Handicap Index-10 (VHI-10) score of 11 or higher
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:

No movement disorders of the vocal fold including paralysis
Airway disease caused by burn
History of malignant tumor
History of allergy to local anesthesia agent
With impaired coagulation-fibrinolysis, or taking anticoagulant or antiplatelet drugs
Serious concomitant disease
Pregnant (including suspected), nursing, wishing to become pregnant, or unable to prevent conception during the trial period using contraceptive methods

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daichika Hayata	Kringle Pharma, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fujita Health University Hospital		Toyoake	Aichi-ken	470-1192	Japan
Fukuoka Sanno Hospital

Condition Browse Module

MeSH Terms

ID	Term
C564265	Deafness, Autosomal Recessive 39

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017228	Hepatocyte Growth Factor

Ancestor Terms

ID	Term
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided