Phase 2 Study of KH001 in Long-term Relief From Dentin Hy... | NCT06464939

Studies
Phase 2 Study of KH001 in Long-term Relief From Dentin Hypersensitivity

NCT06464939

Sponsor

HysensBio Co., Ltd

Status

Completed

Last Update Posted

Jan 13, 2026Actual

Enrollment

120Actual

Phase

Phase 2

Conditions

Dentin Hypersensitivity

Interventions

KH001
Placebo

Countries

United States

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

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 8, 2024Actual

Primary Completion Date

Dec 22, 2025Actual

Completion Date

Dec 22, 2025Actual

First Submitted Date

Jun 13, 2024

First Submission Date that Met QC Criteria

Jun 13, 2024

First Posted Date

Jun 18, 2024Actual

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

Jan 11, 2026

Last Update Posted Date

Jan 13, 2026Actual

Name	Class
The Forsyth Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

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 evaluate the efficacy and safety of KH001 in subjects with dentin hypersensitivity.

Detailed Description

The study will consist of a screening period, a treatment period, and a follow-up period. The total duration of the study for each subject will be approximately 8 to 12 weeks. All subjects will be randomly assigned in a 1:1:1 ratio, with Group A, Group B and Group C.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	KH001 and placebo	Drug: KH001 Drug: Placebo
Group B	Experimental	KH001 and placebo	Drug: KH001 Drug: Placebo
Group C	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KH001	Drug	Applications of KH001 over a 1 or 2-week period, and application of placebo	Group A Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in Schiff sensitivity score	Schiff sensitivity score 0-3 by an evaporative air	Baseline and Week 5

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in a Schiff sensitivity score	Schiff sensitivity score 0-3 by an evaporative air	Baseline, Up to 8 Weeks
Change from baseline in a Tactile threshold	Tactile threshold by yeaple probe

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Is at least 18 years old by the time of the screening visit
Is in good general health as determined by the investigator
Has at least 2 non-adjacent teeth and is diagnosed with hypersensitive

Exclusion Criteria:

Is allergic to the active drug substance or other excipients used in the investigational product
Has any history of alcohol or drug abuse
Has received any treatment related to dentin hypersensitivity within 8 weeks prior to the screening visit
Is jedged by the investigator as ineligible for participation for other reasons

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hatice Hasturk	ADA Forsyth	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ADA Forsyth		Cambridge	Massachusetts	02142	United States
Forsyth Institute

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003807	Dentin Sensitivity

Ancestor Terms

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided