Back to resultsEvaluation of the Safety and Tolerability of KH001 in Dentin Hypersensitivity Patients
Primary Purpose
Dentin Sensitivity
Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
KH001
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dentin Sensitivity focused on measuring Dentin regeneration, Hypersensitivity, Sensitivity, Tooth sensitivity
Eligibility Criteria
[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
Sites / Locations
- Seoul National University Dental HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
KH001
Placebo
Arm Description
The study consists of sequential dosing cohorts, 8 subjects per cohort will be administered KH001 or placebo.
The study consists of sequential dosing cohorts, 8 subjects per cohort will be administered KH001 or placebo.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change from baseline in VAS(Visual Analogue Score).
VAS scale (0-100mm)
Maximum plasma concentration (Cmax) of KH001 single and multiple ascending dose.
Pharmacokinetics parameter derived from plasma
Area under the concentration-time curve (AUC) of KH001 single and multiple ascending dose
Pharmacokinetics parameter derived from plasma
Time to reach maximum concentration (Tmax) of KH001 single and multiple ascending dose
Pharmacokinetics parameter derived from plasma
Elimination half life (t½) of KH001 single and multiple ascending dose
Pharmacokinetics parameter derived from plasma
Estimate of apparent clearance (CL/F) of KH001 single and multiple ascending dose
Pharmacokinetics parameter derived from plasma
Change from Baseline in Evaporative Air Sensitivity and Tactile Threshold
pain intensity assessed by 0-3 scale
Change from baseline in Dentine Hypersensitivity Experience Questionnaire
assessed by questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04804514
Brief Title
Evaluation of the Safety and Tolerability of KH001 in Dentin Hypersensitivity Patients
Official Title
Phase 1/2a Study of KH001 in Dentin Hypersensitivity Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 26, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HysensBio Co., Ltd
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity
Keywords
Dentin regeneration, Hypersensitivity, Sensitivity, Tooth sensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
KH001
Arm Type
Experimental
Arm Description
The study consists of sequential dosing cohorts, 8 subjects per cohort will be administered KH001 or placebo.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The study consists of sequential dosing cohorts, 8 subjects per cohort will be administered KH001 or placebo.
Intervention Type
Drug
Intervention Name(s)
KH001
Intervention Description
The study drug is applied to teeth
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The placebo is applied to teeth
Primary Outcome Measure Information:
Title
Number of subjects with adverse events(AEs)
Description
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
Time Frame
up to 22 days and 36 days
Secondary Outcome Measure Information:
Title
Change from baseline in VAS(Visual Analogue Score).
Description
VAS scale (0-100mm)
Time Frame
up to 22 days and 36 days
Title
Maximum plasma concentration (Cmax) of KH001 single and multiple ascending dose.
Description
Pharmacokinetics parameter derived from plasma
Time Frame
0~24 hours
Title
Area under the concentration-time curve (AUC) of KH001 single and multiple ascending dose
Description
Pharmacokinetics parameter derived from plasma
Time Frame
0~24 hours
Title
Time to reach maximum concentration (Tmax) of KH001 single and multiple ascending dose
Description
Pharmacokinetics parameter derived from plasma
Time Frame
0~24 hours
Title
Elimination half life (t½) of KH001 single and multiple ascending dose
Description
Pharmacokinetics parameter derived from plasma
Time Frame
0~24 hours
Title
Estimate of apparent clearance (CL/F) of KH001 single and multiple ascending dose
Description
Pharmacokinetics parameter derived from plasma
Time Frame
0~24 hours
Title
Change from Baseline in Evaporative Air Sensitivity and Tactile Threshold
Description
pain intensity assessed by 0-3 scale
Time Frame
up to 22 days and 36 days
Title
Change from baseline in Dentine Hypersensitivity Experience Questionnaire
Description
assessed by questionnaire
Time Frame
up to 22 days and 36 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
[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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minjoung Choi
Phone
+82-2-502-6700
Email
joychoi@hysensbio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Juyoung Ryu
Phone
+82-2-883-2155
Email
jyryu@hysensbio.com
Facility Information:
Facility Name
Seoul National University Dental Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
won jun Shon, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
HysensBio Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Learn more about this trial
Evaluation of the Safety and Tolerability of KH001 in Dentin Hypersensitivity Patients
We'll reach out to this number within 24 hrs