NCT04804514已完成1 期
Phase 1/2a Study of KH001 in Dentin Hypersensitivity Patients
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse events(AEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
KH001
Experimental
The study consists of sequential dosing cohorts, 8 subjects per cohort will be administered KH001 or placebo.
干预措施: KH001 (Drug)
Placebo
Placebo Comparator
The study consists of sequential dosing cohorts, 8 subjects per cohort will be administered KH001 or placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with adverse events(AEs)
时间窗: 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
次要结局
- Change from baseline in Dentine Hypersensitivity Experience Questionnaire(up to 22 days and 36 days)
- Estimate of apparent clearance (CL/F) of KH001 single and multiple ascending dose(0~24 hours)
- 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)
- Change from Baseline in Evaporative Air Sensitivity and Tactile Threshold(up to 22 days and 36 days)
- Change from baseline in VAS(Visual Analogue Score).(up to 22 days and 36 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study to Evaluate the Efficacy and Safety of KH001 in Patients with Dentin HypersensitivityDentin HypersensitivityNCT06264453HysensBio Co., Ltd171
已完成
2 期
Phase 2 Study of KH001 in Long-term Relief From Dentin HypersensitivityDentin HypersensitivityNCT06464939HysensBio Co., Ltd120
已完成
2 期
A Study to Evaluate Physiologic Dentin Regeneration and Safety of KH001 in the Administration of Erupted Wisdom Tooth With Dentin CariesDentin CariesNCT06580678Byoung-Moo Seo12
已完成
不适用
A Clinical Study to Evaluate the Anti-Sensitivity Effect of a Calcium Sodium Phosphosilicate Toothpaste in a Population of Dentin Hypersensitivity SufferersDentin SensitivityNCT06378008HALEON217
尚未招募
不适用
Study on treatment for dentin hypersensitivitydentin hypersensitivityDRKS00004663Klinik für Zahnerhaltungskunde & Parodontologie, Universitätsklinikum Freiburg120