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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KH001 | Experimental | The study consists of sequential dosing cohorts, 8 subjects per cohort will be administered KH001 or placebo. |
|
| Placebo | Placebo Comparator | The study consists of sequential dosing cohorts, 8 subjects per cohort will be administered KH001 or placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KH001 | Drug | The study drug is applied to teeth |
| |
| Placebo |
| 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 |
| 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 |
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[Inclusion criteria]
[Exclusion criteria]
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Dental Hospital | Seoul | South Korea |
HysensBio Inc. will not be sharing individual de-identified participant data or other relevant study documents.
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| ID | Term |
|---|---|
| D003807 | Dentin Sensitivity |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007154 | Immune System Diseases |
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| Drug |
The placebo is applied to teeth |
|
| 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 |