Status:
COMPLETED
Evaluation of the Safety and Tolerability of KH001 in Dentin Hypersensitivity Patients
Lead Sponsor:
HysensBio Co., Ltd
Conditions:
Dentin Sensitivity
Eligibility:
All Genders
19-65 years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- \[Inclusion criteria\]
- 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
Exclusion
Key Trial Info
Start Date :
June 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04804514
Start Date
June 14 2021
End Date
March 3 2023
Last Update
February 26 2025
Active Locations (1)
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1
Seoul National University Dental Hospital
Seoul, South Korea