A Randomized, Double-blind, Placebo-controlled Single and Multiple Dose Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Topical Ointment YR001 in Adult Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Part B: Safety and Maximum Tolerate Dose (MTD)
研究概览
简要总结
This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in healthy adult subjects.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent obtained from the subject
- •Male or female subject is aged between 18 and 65 years
- •Subject has a weight of at least 50 kg and a body mass index (BMI) between 18.0 and 30.0 kg/m2
- •Free from any clinically relevant illness or disease incl. skin disorder that may adversely affect the safety of the subject or the integrity of the study
排除标准
- •Presence or history of a clinically significant medical condition or other condition that might interfere with the safety, tolerability and PK assessment of ointment YR001, or place the subject at an unacceptable risk as a subject in this study.
- •Pregnant or lactating women.
- •Any skin tattoo, scar, cuts, bruises, or other skin damage, including excessive UV exposure, at the possible IP application sites.
- •Have concomitant skin disease or infection (e.g., acne, impetigo) or presence of skin comorbidities in the skin areas to be dosed that may interfere with study assessments and treatment response.
- •Have active infectious disease.
- •Subjects treated with another investigational drug, biological agent, or device
- •Participation in another interventional clinical trial before entering, or during the trial, or previous participation in this clinical trial.
- •Evidence of clinically important cardiac conduction abnormalities at screening as judged by ECG.
- •Active untreated mental or psychiatric disorder.
- •Any major surgery within 6 months of screening.
- •Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
- •Drug or alcohol abuse history.
研究组 & 干预措施
Part A, Active dose A and Low body surface area
The intervention is YR001 Dose A on low body surface area, low dose YR001 for single topical administration
干预措施: YR001 Dose A on low body surface area (Drug)
Part A, Active dose A and Middle body surface area
The intervention is YR001 Dose A on middle body surface area, low dose for single topical administration
干预措施: YR001 Dose A on middle body surface area (Drug)
Part A, Active dose A and High body surface area
The intervention is YR001 Dose A on high body surface area, low dose for single topical administration
干预措施: YR001 Dose A on high body surface area (Drug)
Part A, Active dose B and Low body surface area
The intervention is YR001 Dose B on low body surface area, high dose YR001 for single topical administration
干预措施: YR001 Dose B on low body surface area (Drug)
Part A, Active dose B and Middle body surface area
The intervention is YR001 Dose B on middle body surface area, high dose YR001 for single topical administration
干预措施: YR001 Dose B on middle body surface area (Drug)
Part A, Active dose B and High body surface area
The intervention is YR001 Dose B on high body surface area, high dose YR001 for single topical administration
干预措施: YR001 Dose B on high body surface area (Drug)
Part A, Placebo and Low body surface area
The intervention is Placebo on low body surface area, Placebo for single topical administration
干预措施: Placebo on low body surface area (Drug)
Part A, Placebo and Middle body surface area
The intervention is Placebo on middle body surface area, Placebo for single topical administration
干预措施: Placebo on middle body surface area (Drug)
Part A, Placebo and High body surface area
The intervention is Placebo on high body surface area, Placebo for single topical administration
干预措施: Placebo on high body surface area (Drug)
Part B, Active dose A and High body surface area
The intervention is YR001 Dose A on high body surface area twice daily, low dose YR001 for multiple topical administration
干预措施: YR001 Dose A on high body surface area twice daily (Drug)
Part B, Active dose B and High body surface area
The intervention is YR001 Dose B on high body surface area twice daily, high dose YR001 for multiple topical administration
干预措施: YR001 Dose B on high body surface area twice daily (Drug)
Part B, Placebo and High body surface area
The intervention is Placebo on high body surface area twice daily, Placebo for multiple topical administration
干预措施: Placebo on high body surface area twice daily (Drug)
结局指标
主要结局
Part B: Safety and Maximum Tolerate Dose (MTD)
时间窗: day 0 to day 22
Incidence of treatment related AEs (TRAEs) and local skin tolerance
Part A: Safety and Maximum Tolerate Dose (MTD)
时间窗: day 0 to day 8
Incidence of treatment related AEs (TRAEs) and local skin tolerance
次要结局
- Part B: all treatment-emergent AEs(day 0 to day 22)
- Part A: all treatment-emergent AEs(day 0 to day 8)