NCT05324293已完成1 期
An Open Label Study, to Evaluate Safety, Tolerability, and Efficacy in Male and Female With Androgenetic Alopecia Treated With HMI-115 Over a 24-Week Treatment Period
Hope Medicine (Nanjing) Co., Ltd1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年5月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- TAHC(target area hair count) of non-vellus
研究概览
简要总结
An Open Label Study, to Evaluate Safety, Tolerability, and Efficacy Study in Male and Female with Androgenetic Alopecia Treated with HMI-115 over a 24-Week Treatment Period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
- •Male and Female subjects, between 18 and 65 years of , inclusive, at the time of signing informed consent.
- •Clinical diagnosis of androgenetic alopecia. Male subjects who meet Norwood-Hamilton scales 3v, 4 and
- •Female subjects who meet Sinclair scales 2-4.
排除标准
- •Subject with clinical diagnosis of non-AGA
- •Subject with clinically relevant abnormal skin or scalp findings which could interfere study assessment
- •Subject has used therapies associated with hair growth or may affect PRL levels, within defined time window before Screening
- •Subject with history of anterior pituitary, posterior pituitary, or hypothalamic dysfunction
- •Subject has clinically significantly abnormal laboratory tests at Screening
- •Known hypersensitivity to any of the IMP ingredients
- •Any other conditions in the investigator's opinion that prevent the subject from participating
研究组 & 干预措施
HMI-115 240mg
Experimental
干预措施: HMI-115 (Drug)
结局指标
主要结局
TAHC(target area hair count) of non-vellus
时间窗: From baseline to Week 24
Change in target area hair count (TAHC) of non-vellus from baseline to Week 24 in male and female AGA subjects, respectively.
次要结局
- Investigator Global Assessment (IGA)(Week 6, 12, 18, 24, and 36)
- TAHC of non-vellus(From baseline to Week 6, 12, 18, and 36)
- TAHW(target area hair width) of non-vellus hair(From baseline to Week 6, 12, 18, 24, and 36)
- Subject self-Assessment (SSA)(Week 6, 12, 18, 24, and 36)
- Hair growth questionnaire assessment (HGQA)(Week 6, 12, 18, 24, and 36)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Open Label Study to Assess the Pharmacokinetics of Intranasal Ketorolac Tromethamine Following Fluticasone Propionate in Healthy SubjectsHealthy SubjectsNCT01365611Egalet Ltd36
已完成
2 期
A Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical SolutionAndrogenetic AlopeciaNCT03495817Aclaris Therapeutics, Inc.31
已完成
1 期
A Single and Multiple Dose Study to Assess Blood and Urine Drug Levels of Fostamatinib in Healthy Japanese SubjectsHealthy Japanese VolunteersNCT01608542AstraZeneca24
已完成
1 期
ExpressGraft-C9T1 Skin Tissue as a Treatment of Diabetic Foot UlcersDiabetesNon-healing WoundDiabetic Foot UlcerNCT02657876Stratatech, a Mallinckrodt Company5
已完成
2 期
A Study to Evaluate the Safety and Pharmacokinetics of Ataluren in Participants From ≥6 Months to <2 Years of Age With Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD)Nonsene Mutation Duchenne Muscular DystrophyNCT04336826PTC Therapeutics6