Dentin SensitivityPhase 1/2NCT04804514
Evaluation of the Safety and Tolerability of KH001 in Dentin Hypersensitivity Patients
A Phase 1/2 study testing KH001 in people with Dentin Sensitivity, run by HysensBio Co., Ltd at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Dentin Sensitivity
- What is being tested?
- KH001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Jun 2021to 3 Mar 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
[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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Dentin Sensitivity
- Being tested
- KH001, Placebo
- Keywords
- Dentin regeneration, Hypersensitivity, Sensitivity, Tooth sensitivity
- Medical subject headings
- Dentin Sensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KH001Drug
The study drug is applied to teeth
PlaceboDrug
The placebo is applied to teeth
| Study group | Role | What they receive |
|---|---|---|
| KH001 | Experimental | The study consists of sequential dosing cohorts, 8 subjects per cohort will be administered KH001 or placebo. Receives: Drug: KH001 |
| Placebo | Placebo comparator | The study consists of sequential dosing cohorts, 8 subjects per cohort will be administered KH001 or placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 22 days and 36 days
Secondary outcomes (8)
Change from baseline in VAS(Visual Analogue Score).
VAS scale (0-100mm)
Measured: up to 22 days and 36 days
Maximum plasma concentration (Cmax) of KH001 single and multiple ascending dose.
Pharmacokinetics parameter derived from plasma
Measured: 0~24 hours
Area under the concentration-time curve (AUC) of KH001 single and multiple ascending dose
Pharmacokinetics parameter derived from plasma
Measured: 0~24 hours
Time to reach maximum concentration (Tmax) of KH001 single and multiple ascending dose
Pharmacokinetics parameter derived from plasma
Measured: 0~24 hours
Elimination half life (t½) of KH001 single and multiple ascending dose
Pharmacokinetics parameter derived from plasma
Measured: 0~24 hours
Estimate of apparent clearance (CL/F) of KH001 single and multiple ascending dose
Pharmacokinetics parameter derived from plasma
Measured: 0~24 hours
Change from Baseline in Evaporative Air Sensitivity and Tactile Threshold
pain intensity assessed by 0-3 scale
Measured: up to 22 days and 36 days
Change from baseline in Dentine Hypersensitivity Experience Questionnaire
assessed by questionnaire
Measured: up to 22 days and 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start14 Jun 2021
- Primary completion3 Mar 2023
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- HysensBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804514
- Sponsor's protocol ID
- KH001sol-01
- Status last verified
- Feb 2025
- First submitted
- 9 Mar 2021
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: HysensBio Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2a Study of KH001 in Dentin Hypersensitivity Patients
- ClinicalTrials.gov ID
- NCT04804514
- Acronym / sponsor ID
- KH001sol-01
- Conditions
- Dentin Sensitivity
- Keywords
- Dentin regeneration, Hypersensitivity, Sensitivity, Tooth sensitivity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- HysensBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KH001 | Experimental | Drug: KH001The study consists of sequential dosing cohorts, 8 subjects per cohort will be administered KH001 or placebo. |
| Placebo | Placebo comparator | Drug: PlaceboThe study consists of sequential dosing cohorts, 8 subjects per cohort will be administered KH001 or placebo. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KH001The study drug is applied to teeth | Drug | KH001 |
| PlaceboThe placebo is applied to teeth | Drug | Placebo |
Primary outcome
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
8 secondary outcomes
Change from baseline in VAS(Visual Analogue Score).
Time frame: up to 22 days and 36 days
Maximum plasma concentration (Cmax) of KH001 single and multiple ascending dose.
Time frame: 0~24 hours
Area under the concentration-time curve (AUC) of KH001 single and multiple ascending dose
Time frame: 0~24 hours
Time to reach maximum concentration (Tmax) of KH001 single and multiple ascending dose
Time frame: 0~24 hours
Elimination half life (t½) of KH001 single and multiple ascending dose
Time frame: 0~24 hours
Estimate of apparent clearance (CL/F) of KH001 single and multiple ascending dose
Time frame: 0~24 hours
Change from Baseline in Evaporative Air Sensitivity and Tactile Threshold
Time frame: up to 22 days and 36 days
Change from baseline in Dentine Hypersensitivity Experience Questionnaire
Time frame: up to 22 days and 36 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: No. HysensBio Inc. will not be sharing individual de-identified participant data or other relevant study documents.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing KH001 in people with Dentin Sensitivity, run by HysensBio Co., Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events(AEs) (time frame: up to 22 days and 36 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.