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

Phase 1

Completed

• Conditions: Dentin Sensitivity
• Interventions: Drug: KH001; Drug: Placebo

• Registration Number: NCT04804514
• Lead Sponsor: HysensBio Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-18
• Study Start: 2021-06-14
• Primary Completion: 2023-03-03
• Study Completion: 2023-03-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
KH001	KH001	The study consists of sequential dosing cohorts, 8 subjects per cohort will be administered KH001 or placebo.
Placebo	Placebo	The study consists of sequential dosing cohorts, 8 subjects per cohort will be administered KH001 or placebo.

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events(AEs)	up to 22 days and 36 days	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Dental Hospital; 🇰🇷 Seoul, Korea, Republic of