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

• Status: Completed
• Trial end date: 2019-09-19
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fountain Biopharma Inc.

Criteria

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.