NCT07402330尚未招募1 期
Pharmacokinetic Study of DA-020
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Concentration of DA-020 in Serum
研究概览
简要总结
Pharmacokinetic Study of DA-020
详细描述
A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics of DA-020
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy females, age 18-55
- •BMI: 18-30 kg/m²
- •Fitzpatrick Skin Types I-IV (to standardize absorption risk)
- •Scalp free from irritation, dermatologic disease, or damage
- •Able to refrain from using other topical scalp products
排除标准
- •History of cardiovascular disease, hypertension, or arrhythmia
- •Scalp infections, wounds, or significant hair loss
- •Recent use of medications that interfere with CYP enzymes or adrenergic systems
- •Known sensitivity to phenylephrine or ethanol
- •Positive drug screen or abnormal ECG at screening
研究组 & 干预措施
DA-020 (0.1%)
Experimental
Topical Oxymetazoline 0.1% - 7mL
干预措施: DA-020 (0.1%) (Drug)
DA-020 (0.2%)
Experimental
Topical Oxymetazoline 0.2% - 7mL
干预措施: DA-020 (0.2%) (Drug)
DA-020 (0.5%)
Experimental
Topical Oxymetazoline 0.5% - 7mL
干预措施: DA-020 (0.5%) (Drug)
结局指标
主要结局
Concentration of DA-020 in Serum
时间窗: Hours [0, 1, 2, 4, 8, 12, 24]
Determine the amount of Oxymetazoline in serum after 1 time scalp application
次要结局
- Safety and tolerability of DA-020(Hours [0, 1, 2, 4, 8, 12, 24])
研究者
研究点 (2)
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