EUCTR2005-002077-76-GB进行中(未招募)1 期
A Phase 2a Study To Investigate The Effects of Repeated Administration of AeroDerm in subjects with Atopic Eczema.
Aerovance Inc0 个研究点目标入组 24 人开始时间: 2005年5月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Adult males and females > 18 years.
- •Subjects who currently have allergic eczema with an EASI score in the range of 10-35. Subjects with an EASI score in the range of 36-50 may be included at the discretion of the Investigator.
- •Subjects who have been on a stable dose of topical medications for eczema for = 1 month from screening but whose eczema is not adequately responsive to, or controlled by, conventional topical treatments (eg: topical steroids, Tracrolimus, Pimecrolimus).
- •Subjects who have not had systemic immunosuppressive therapy (eg systemic steroids) within 1 month of screening.
- •Subjects who if female, are not currently pregnant or breast feeding and are using medically acceptable methods of contraception.
- •Subjects who have a pre-study medical history, physical examination and vital signs acceptable to the investigator.
- •Subjects who have clinical laboratory tests within the reference ranges or clinically acceptable to the investigator.
- •Subjects who are negative for HbsAg, hepatitis C antibody and HIV II and I test at screening.
- •Subjects who are negative for drugs of abuse tests at screening and admission.
- •Subjects with stable, adequately treated medical conditions other than eczema may be enrolled provided the Investigator does not consider their study participation to place them at increased risk of adverse events. Subjects should continue their concomitant treatments for medical conditions (other than eczema).
- •Subjects who are able and willing to give written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects who do not conform to the above inclusion criteria.
- •Subjects who have the following medical conditions: Diabetes mellitus, Thyroiditis, Rheumatiod arthritis, Multiple sclerosis, Uveitis, Sarcoidosis, Glomerulonephritis, Helminthic infection.
- •Subjects who have a history of relevant drug hypersensitivity.
- •Subjects who have a history of alcoholism.
- •Subjects who have a history of drug abuse.
- •Subjects who have a significant infection at the time of screening and/or admission.
- •Subjects who are having acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn), may be asked to reschedule their screening and/or admission to when they are not longer having acute symptoms.
- •Subjects who have an acute infection such as influenza at the time of screening and/or admission.
- •Female subjects who are not using an acceptable method of contraception.
- •Subjects who have used any investigational drug and /or participated in any clinical trial within 3 months of their first dosing.
- •Subjects who have previously received AeroDerm.
- •Subjects using medication, which in the opinion of the Investigator will affect the outcome of the study.
- •Subjects who have donated and/or received any blood or blood products within the previous 3 months prior to first dosing (to review on a case by case basis).
- •Subjects who cannot communicate reliably with the investigator.
- •Subjects who are unlikely to co-operate with the requirements of the study.
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