SAD and MAD Study of KH001 in Dentin Hypersensitivity Patients

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HysensBio Co., Ltd

Criteria

Inclusion Criteria:

• Before registering, individuals must be fully aware of the purpose and content of the clinical study, and the characteristics of the Investigational Product, and sign written consent of their free will to participate in the study

• Individuals must be between 19 and 65 of age by the time of the screening

• Individuals must have at least 20 natural teeth and two non-contiguous teeth (incisors, canines, or pre-molars) that could be assessed

• Individuals experiencing more than four (two or more on each side) dental symptoms, clinically satisfy all the diagnostic criteria below, and are diagnosed with Dentin Hypersensitivity.

Exclusion Criteria:

• Individuals allergic to the main component or other constituent included in the Investigational Product

• Individuals with medical history including, but not limited to, clinically related allergies, such as drug allergy, asthma, eczema, or anaphylaxis.

• Individuals currently experiencing Xerostomia or Xerostomia-provoking medical conditions, or taking drugs, such as antihistamine, diuretic, or amoxapine that may cause Xerostomia.

• Individuals currently taking anti-inflammatory analgesic drugs.

• Medically compromised patients with conditions related to Dentin Hypersensitivity, such as Gastroesophageal Reflux Disease.

• Individuals who are pregnant or lactating.

• Individuals with a medical history of alcohol or drug abuse (especially drugs that affect the central nervous system, such as sleeping pills, opiates, and psychoactive drugs).

• Individuals who cannot use contraceptive methods permitted for subjects from the date of the written consent to the final visit (e.g. Copper Intrauterine Device (IUD, or copper loop), Intrauterine System (IUS), condom, vasectomy, tubal surgery, spermicide, NuvaRing, subdermal implant, female condom, combined oral contraceptive pill (COCP)).

• Individuals who need prophylactic antibiotics for dental treatment.

• Individuals who participated in an intervention trial within 30 days of screening.

• Individuals whose ALT/AST or creatinine is over three times the normal limit at screening.

• Individuals assessed by the investigator as unsuitable to participate for other reasons.

• Individuals who have received any treatment related to Dentin Hypersensitivity within 8 weeks prior to screening.

• Individuals who have received Dentin Bleaching treatment within 8 weeks prior to the screening.

• Individuals who have received scaling or root planting within 12 weeks prior to screening.

• Individuals who have had periodontal disease. (Probing depth (PD)>3mm)

• Individuals with a partial denture or braces.

• Individuals with active dental caries.

• Individuals with pierced lips or tongue.

• Individuals who used dentin hypersensitivity paste within 6 weeks.

• Dentals that currently have dental caries or have a medical history of dental caries within the past 12 months.

• Dentals that are being used as an abutment for fixed, removable partial dentures.

• Dentin that receives excessive stress.

• Hypersensitivity due to conditions other than dentin exposure, such as corrosion, wear, or facial/cervical gingival recession.