Dentin Sensitivity
Conditions
Keywords
Dentin regeneration, Hypersensitivity, Sensitivity, Tooth sensitivity
Brief summary
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.
Interventions
DRUGPlacebo
The placebo is applied to teeth
DRUGKH001
The study drug is applied to teeth
Sponsors
HysensBio Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
\[Inclusion criteria\] 1. 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; 2. Subjects having at least 20 natural teeth and two teeth that could be assessed 3. Subjects is diagnosed with dentin hypersensitivity, has experienced dental symptoms of two or more teeth \[
Exclusion criteria
\] 1. Subjects is allergic to the active substance or other excipients used in the Investigational Product 2. Subjects has any history of clinically significant allergy, such as drug allergy, asthma, eczema, or anaphylaxis 3. Subjects has any disease related to dentin hypersensitivity 4. Subjects taking anti-inflammatory analgesic drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with adverse events(AEs) | up to 22 days and 36 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration (Cmax) of KH001 single and multiple ascending dose. | 0~24 hours | Pharmacokinetics parameter derived from plasma |
| Area under the concentration-time curve (AUC) of KH001 single and multiple ascending dose | 0~24 hours | Pharmacokinetics parameter derived from plasma |
| Time to reach maximum concentration (Tmax) of KH001 single and multiple ascending dose | 0~24 hours | Pharmacokinetics parameter derived from plasma |
| Change from baseline in VAS(Visual Analogue Score). | up to 22 days and 36 days | VAS scale (0-100mm) |
| Estimate of apparent clearance (CL/F) of KH001 single and multiple ascending dose | 0~24 hours | Pharmacokinetics parameter derived from plasma |
| Change from Baseline in Evaporative Air Sensitivity and Tactile Threshold | up to 22 days and 36 days | pain intensity assessed by 0-3 scale |
| Change from baseline in Dentine Hypersensitivity Experience Questionnaire | up to 22 days and 36 days | assessed by questionnaire |
| Elimination half life (t½) of KH001 single and multiple ascending dose | 0~24 hours | Pharmacokinetics parameter derived from plasma |
Countries
South Korea
Outcome results
None listed