A Study to Evaluate the Efficacy and Safety of KH001 in Patients with Dentin Hypersensitivity

HysensBio

Status and phase: Completed; Phase 2

Conditions: Dentin Hypersensitivity

Treatments: Drug: KH001; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06264453

KH-001-D201

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of KH001 in patients with dentin hypersensitivity.

Full description

This study is multicenter, double-blind, placebo-controlled, randomized, parallel-designed, phase 2 study to evaluate the efficacy and safety of KH001. The total duration of the study will be approximately 7 to 11 weeks. Clinical safety evaluations will include physical examinations, vital signs, clinical laboratory results, and Adverse Event monitoring.

Enrollment: 171 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is at least 19 years old by the time of the screening visit
• Be in good general health as determined by the investigator
• Have 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
• Has active dental caries or history of dental caries

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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171 participants in 3 patient groups, including a placebo group

Group A

Experimental group

Description:

KH001 0.2mg/mL

Treatment:

Drug: KH001

Group B

Experimental group

Description:

KH001 0.4mg/mL

Treatment:

Drug: KH001

Group C

Placebo Comparator group

Description:

Water for Injection

Treatment:

Drug: Placebo