NCT07490327尚未招募1 期
A Randomized, Open-label, Single and Multiple-dose, Parallel-design Phase 1/2a Clinical Trial to Evaluate the Pharmacokinetics/Pharmacodynamics and Safety of AD-303A and Oral Administration of AD-3031 in Male Androgenetic Alopecia Patients
Moogene Medi Co., Ltd1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年4月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax) of dutasteride
研究概览
简要总结
This is a randomized, open-label phase 1/2a study designed to evaluate the pharmacokinetics, pharmacodynamics, and safety of AD-303A (topical formulation) and AD-3031 in male patients with androgenetic alopecia. The study aims to compare pharmacological characteristics and safety profiles to support dose selection for further clinical development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Allocation, Randomized, Open label
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male participants aged 19 to 55 years.
- •Clinical diagnosis of androgenetic alopecia.
- •Healthy as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests.
- •Willing and able to comply with all study procedures and visit schedules.
排除标准
- •History or presence of dermatologic conditions affecting the scalp other than androgenetic alopecia.
- •Prior hair transplantation or scalp surgery that may affect evaluation of hair growth.
- •Use of medications known to affect hair growth (e.g., finasteride, dutasteride, minoxidil) within 6 months prior to screening.
结局指标
主要结局
Maximum observed plasma concentration (Cmax) of dutasteride
时间窗: Up to Day14
The maximum observed plasma concentration (Cmax) of dutasteride following administration of the study drug.
次要结局
- Change from baseline in scalp dihydrotestosterone (DHT) concentration Description(Baseline to Day 8)
研究者
研究点 (1)
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