Evaluation of the Safety and Tolerability of KH001 in Dentin Hypersensitivity Patients

Study Overview
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Brief Summary
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This is a phase 1/2a study in dentin hypersensitivity patients to assess the safety, tolerability, efficacy and pharmacokinetics of single and multiple doses of KH001.

Official Title
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Phase 1/2a Study of KH001 in Dentin Hypersensitivity Patients

Conditions
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Dentin Sensitivity

Intervention / Treatment
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* Drug: KH001
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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[Inclusion criteria] Subjects must be fully aware of the purpose and the content of the study, and the characteristics of the Investigational Product to sign written consent of their free will to take part in the study; Subjects having at least 20 natural teeth and two teeth that could be assessed Subjects is diagnosed with dentin hypersensitivity, has experienced dental symptoms of two or more teeth [Exclusion criteria] Subjects is allergic to the active substance or other excipients used in the Investigational Product Subjects has any history of clinically significant allergy, such as drug allergy, asthma, eczema, or anaphylaxis Subjects has any disease related to dentin hypersensitivity Subjects taking anti-inflammatory analgesic drugs

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KH001<br>The study consists of sequential dosing cohorts, 8 subjects per cohort will be administered KH001 or placebo. | Drug: KH001<br>* The study drug is applied to teeth<br>|
| Placebo Comparator: Placebo<br>The study consists of sequential dosing cohorts, 8 subjects per cohort will be administered KH001 or placebo. | Drug: Placebo<br>* The placebo is applied to teeth<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events(AEs) | The safety and tolerability of KH001 single and multiple ascending dose are evaluated. Adverse event(AE) is based on abnormal clinical laboratory tests, physical exam results and other medically assessments | up to 22 days and 36 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in VAS(Visual Analogue Score). | VAS scale (0-100mm) | up to 22 days and 36 days | 
| Maximum plasma concentration (Cmax) of KH001 single and multiple ascending dose. | Pharmacokinetics parameter derived from plasma | 0 24 hours | 
| Area under the concentration-time curve (AUC) of KH001 single and multiple ascending dose | Pharmacokinetics parameter derived from plasma | 0 24 hours | 
| Time to reach maximum concentration (Tmax) of KH001 single and multiple ascending dose | Pharmacokinetics parameter derived from plasma | 0 24 hours | 
| Elimination half life (t½) of KH001 single and multiple ascending dose | Pharmacokinetics parameter derived from plasma | 0 24 hours | 
| Estimate of apparent clearance (CL/F) of KH001 single and multiple ascending dose | Pharmacokinetics parameter derived from plasma | 0 24 hours | 
| Change from Baseline in Evaporative Air Sensitivity and Tactile Threshold | pain intensity assessed by 0-3 scale | up to 22 days and 36 days | 
| Change from baseline in Dentine Hypersensitivity Experience Questionnaire | assessed by questionnaire | up to 22 days and 36 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dentin regeneration, Hypersensitivity, Sensitivity, Tooth sensitivity