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

NCT04804514 | Completed Phase 1

• 1 other identifier: KH001sol-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentin Sensitivity

Keywords

Dentin regeneration; Hypersensitivity; Sensitivity; Tooth sensitivity

Outcome Measures

Primary Outcomes (1)

• 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

  up to 22 days and 36 days

Secondary Outcomes (8)

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

  up to 22 days and 36 days

• 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

Study Arms (2)

KH001

EXPERIMENTAL

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

Drug: KH001

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

KH001 DRUG

The study drug is applied to teeth

KH001

Placebo DRUG

The placebo is applied to teeth

Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HysensBio Co., Ltd: lead

Study Sites (1)

Seoul National University Dental Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Dentin Sensitivity; Hypersensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 18, 2021
• Study Start: June 14, 2021
• Primary Completion: March 3, 2023
• Study Completion: March 3, 2023
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)