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

HysensBio Co., Ltd1 site in 1 country40 target enrollmentJune 14, 2021

ConditionsDentin Sensitivity

InterventionsKH001 Placebo

Overview

Phase: Phase 1
Intervention: KH001
Conditions: Dentin Sensitivity
Sponsor: HysensBio Co., Ltd
Enrollment: 40
Locations: 1
Primary Endpoint: Number of subjects with adverse events(AEs)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 14, 2021

End Date

March 3, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

HysensBio Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

KH001

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

Intervention: KH001

Placebo

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

Intervention: Placebo

Outcomes

Primary Outcomes

Number of subjects with adverse events(AEs)

Time Frame: 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 Outcomes

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