A Single Centre, Randomized, Investigator Blinded, Placebo-controlled Ascending Dose Study to Assess the Local Safety, the Skin and Plasma Concentration of Azithromycin Dermal Formulation During Repeated Applications on the Skin of Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Local safety
研究概览
简要总结
IXODES GmbH intends to develop SHB001, an azithromycin dermal formulation in order to prevent Lyme disease at early stages of infection after tick bite.
详细描述
In this study two consecutive cohorts will be treated:
- Cohort 1: 8 volunteers
- Cohort 2: 24 volunteers, divided into 3 groups of 8 subjects each
The study will be conducted in the following three phases:
-
Treatment of cohort 1: The aim is to establish the maximal tolerated dose (MTD) for a local treatment with azithromycin dermal formulation.
-
Treatment of cohort 1 with azithromycin dermal formulation and follow up
-
Assessment of local safety within the 7 days following the first treatment
-
The maximal tolerated dose (MTD) will be determined
-
Treatment of cohort 2: The aim is to confirm the local tolerance of the selected doses and to evaluate the local skin and plasma concentration of azithromycin after application of SHB001 dermal formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Main inclusion criteria:
- •Male or female healthy volunteers, age 18 - 70 years
排除标准
- •A known hypersensitivity against azithromycin, erythromycin or any of the macrolide antibiotics
- •A known hypersensitivity against lidocaine
- •Treatment by any route with any macrolide antibiotic within the last 2 month
结局指标
主要结局
Local safety
时间窗: April 2010 - November 2010
The primary objective of this study is to assess the local safety of azithromycin dermal formulation when applied to healthy skin in healthy volunteers. This will be done by determination (in cohort 1) and confirmation (in cohort 2) of the maximal tolerated dose (MTD) after dermal application of SHB001 in 4 different dose regimens.
次要结局
- Pharmacokinetics of SHB001(April 2010 - November 2010)