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

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

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.

Study Overview

• Status: Completed
• Conditions: Dentin Sensitivity
• Intervention / Treatment: Drug: KH001; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Dental Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

[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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KH001; The study consists of sequential dosing cohorts, 8 subjects per cohort will be administered KH001 or placebo.	Drug: KH001; The study drug is applied to teeth
Placebo Comparator: Placebo; The study consists of sequential dosing cohorts, 8 subjects per cohort will be administered KH001 or placebo.	Drug: Placebo; The placebo is applied to teeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: HysensBio Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Actual): March 3, 2023
• Study Completion (Actual): March 3, 2023

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Hypersensitivity; Sensitivity; Tooth sensitivity; Dentin regeneration
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Immune System Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity
• Other Study ID Numbers: KH001sol-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: HysensBio Inc. will not be sharing individual de-identified participant data or other relevant study documents.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No