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COMPLETEDPHASE1/PHASE2

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

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

NCT04804514•HysensBio Co., Ltd

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.

Eligibility

Age

19 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Seoul National University Dental Hospital

Seoul, South Korea

Key Dates

Start Date

June 14, 2021

Primary Completion Date

March 3, 2023

Completion Date

March 3, 2023

Last Updated

February 26, 2025

Enrollment

ACTUAL participants

Conditions

Dentin Sensitivity

Interventions

KH001

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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