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Completed

NCT Number: NCT04804514

Evaluation of the Safety and Tolerability 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.

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Key information

Conditions

Dentin Sensitivity Hypersensitivity Immune System Diseases Stomatognathic Diseases Tooth Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Seoul National University Dental Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

[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

Treatment and study plan

KH001

Drug

The study drug is applied to teeth

Placebo

Drug

The placebo is applied to teeth

Primary outcomes

  1. 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

  1. Change from baseline in VAS(Visual Analogue Score).

    Time frame: up to 22 days and 36 days

    VAS scale (0-100mm)

  2. Maximum plasma concentration (Cmax) of KH001 single and multiple ascending dose.

    Time frame: 0~24 hours

    Pharmacokinetics parameter derived from plasma

  3. Area under the concentration-time curve (AUC) of KH001 single and multiple ascending dose

    Time frame: 0~24 hours

    Pharmacokinetics parameter derived from plasma

  4. Time to reach maximum concentration (Tmax) of KH001 single and multiple ascending dose

    Time frame: 0~24 hours

    Pharmacokinetics parameter derived from plasma

  5. Elimination half life (t½) of KH001 single and multiple ascending dose

    Time frame: 0~24 hours

    Pharmacokinetics parameter derived from plasma

  6. Estimate of apparent clearance (CL/F) of KH001 single and multiple ascending dose

    Time frame: 0~24 hours

    Pharmacokinetics parameter derived from plasma

  7. Change from Baseline in Evaporative Air Sensitivity and Tactile Threshold

    Time frame: up to 22 days and 36 days

    pain intensity assessed by 0-3 scale

  8. Change from baseline in Dentine Hypersensitivity Experience Questionnaire

    Time frame: up to 22 days and 36 days

    assessed by questionnaire

Sponsors and collaborators

Lead sponsor

HysensBio Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 18, 2021
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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