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

HysensBio

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dentin Sensitivity

Treatments: Drug: Placebo; Drug: KH001

Study type: Interventional

Funder types: Industry

Identifiers

NCT04804514

KH001sol-01

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

[Inclusion criteria]

1. 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;
2. Subjects having at least 20 natural teeth and two teeth that could be assessed
3. Subjects is diagnosed with dentin hypersensitivity, has experienced dental symptoms of two or more teeth

[Exclusion criteria]

1. Subjects is allergic to the active substance or other excipients used in the Investigational Product
2. Subjects has any history of clinically significant allergy, such as drug allergy, asthma, eczema, or anaphylaxis
3. Subjects has any disease related to dentin hypersensitivity
4. Subjects taking anti-inflammatory analgesic drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

KH001

Experimental group

Description:

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

Treatment:

Drug: KH001

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo