NCT03375957已完成1 期
A Single-Site Study To Evaluate the Sensitization Potential of Topically Applied ATx201 in Healthy Human Volunteers
UNION therapeutics1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2018年1月8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
- 240
- 试验地点
- 1
- 主要终点
- Dermal Response Score
研究概览
简要总结
This is a Phase I, single-site study to evaluate the sensitization potential of topically applied ATx201 GEL, 2% and 4%, along with a placebo control, in healthy human subjects.
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 (Outcomes Assessor)
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
- •Good general health
- •Body Mass Index no less than 19.0 and no greater than 36.0 kg/m² (inclusive).
- •Demonstrates a Fitzpatrick skin score of I - IV
- •Female subjects must agree to use acceptable contraceptive methods from the Screening Visit through 90 days after the End of Study (EOS) Visit; or postmenopausal status with no menses for at least 1 year prior to the Screening Visit.
- •Willing to refrain from excessive consumption of sodium in food or beverage 48 hours prior to Day 1 through EOS Visit.
- •Willing to shower using the same non-medicated soap/cleansers, and abstain from excessive sun exposure (including tanning salons) from the Screening Visit through EOS Visit.
排除标准
- •Reports a history of diabetes mellitus, clinically significant asthma (acceptable if no episode within 5 years prior to Day 1), or currently diagnosed with hypertension or circulatory disease.
- •Reports use of any oral, nasal or topical corticosteroids, or oral or topical retinoids (other than Vitamin A at normal dietary amounts)
- •Reports a significant history of allergy to soaps, lotions, emollients, ointments, creams, cosmetics, adhesives, or latex.
- •Reports a history of significant skin conditions or disorders such as psoriasis, atopic dermatitis, etc.
- •Reports a history of significant dermatologic cancers.
- •Displays an obvious difference in skin color between upper arms or upper back or the presence of a skin anomaly
- •Reports smoking or use of tobacco or nicotine delivery products within 14 days prior to Day 1 through EOS Visit.
- •Presence of any clinically significant results from laboratory tests and vital signs assessments, as judged by the Investigator.
- •A female who is pregnant, lactating, breastfeeding, or intends to become pregnant over the course of the study.
- •Reports a history of drug or alcohol addiction or abuse within the past year.
- •Reports having donated blood or plasma within 48 hours prior to Day 1 through EOS Visit.
- •Subject exhibits excessive hair density on the upper arms or back such that patch adhesion could be compromised.
- •Subject reports undergoing hair depilation (e.g. chemical, laser, physical) within 30 days prior to Day 1 through EOS Visit.
研究组 & 干预措施
ATx201 2% Gel
Experimental
干预措施: ATx201 (Drug)
ATx201 4% Gel
Experimental
干预措施: ATx201 (Drug)
ATx201 Gel Placebo
Placebo Comparator
干预措施: ATx201 Placebo Gel (Drug)
结局指标
主要结局
Dermal Response Score
时间窗: 21 days
number of patients with a dermal response score of at least 2
次要结局
- Dermal Response and Effects Score(21 days)
研究者
研究点 (1)
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