An Open-Labeled Exploratory Study to Evaluate Safety and Efficacy of FB825 in Adults With Atopic Dermatitis

An Open-Labeled Exploratory Study to Evaluate Safety and Efficacy of FB825 in Adults With Atopic Dermatitis

The purpose of this study is to evaluate the Safety and Efficacy of FB825 in Adults with Atopic Dermatitis

This is an open-labeled exploratory study to evaluate safety and efficacy of FB825 in adults with atopic dermatitis (AD). The study will be conduct at one medical center in Taiwan.

Approximately 12 subjects with atopic dermatitis (AD), who meet the criteria for study entry, will be enrolled to the one-arm-study.

Inclusion Criteria:

1. Male or female subjects between 20 and 65 years of age, inclusive.
2. The subject has a physician-confirmed diagnosis of chronic atopic dermatitis based on 3 years history of symptoms defined by the Eichenfield revised criteria of Hannifin and Rajka and supported by positive allergen-specific IgE at the screening visit.
3. Eczema Area and Severity Index (EASI) score ≧14 at the screening and baseline visits.
4. Investigator's Global Assessment (IGA) score ≧ 3 (5-point scale) at the screening and baseline visits.
5. ≧10 % body surface area (BSA) of AD involvement at the screening and baseline visits.

Exclusion Criteria:

1. Female subjects who are pregnant or lactating.
2. The subject is on diet or with poor intake.
3. The subject has a history of heart arrhythmias (any clinically relevant).
4. The subject has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 and 2 antibodies at screening.
5. The subject has a history of alcohol or drug abuse that would impair or risk the patients' full participation in the study, in the opinion of the investigator.