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

Dentin Sensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04804514
• Other study ID #: KH001sol-01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 26, 2021
• Est. completion date: August 30, 2023

Study information

• Verified date: October 2023
• Source: HysensBio Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 30, 2023
• Est. primary completion date: March 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

[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

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity

Intervention

Drug:
• KH001
The study drug is applied to teeth
• Placebo
The placebo is applied to teeth

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Dental Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
HysensBio Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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