Evaluate Efficacy, PK, and Safety of FB825 in Adults With Atopic Dermatitis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Atopic Dermatitis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Arm A: FB825 Arm B: PlaceboMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
IgE plays an important role in mediating hypersensitivity reactions responsible for most of the allergic diseases, such as atopic dermatitis, asthma etc. which remain poorly controlled. FB825 blocks the biological pathway of IgE synthesis and thus can be used to treat IgE-mediated allergic diseases....
IgE plays an important role in mediating hypersensitivity reactions responsible for most of the allergic diseases, such as atopic dermatitis, asthma etc. which remain poorly controlled. FB825 blocks the biological pathway of IgE synthesis and thus can be used to treat IgE-mediated allergic diseases. FB825 was found to be safe when given IV repeat dose in toxicology study in monkey. No adverse effects of FB825 were observed in parameters included electrocardiograms for cardiovascular, ophthalmic examinations and other clinical, CNS and respiratory safety observations. The safety and tolerability of FB825 was demonstrated in the US phase I randomized, double-blind study with healthy subjects. Also, the FB825 was proved by in vivo study that it is able to block the biological pathway of IgE synthesis and thus can be used to treat IgE-mediated allergic diseases. Therefore, in this study, the effects of IgE in patients with atopic dermatitis receiving FB825 treatment will be investigated. The study will evaluate safety and efficacy in adults with atopic dermatitis.
Tracking Information
- NCT #
- NCT04413942
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: NienYi Chen, PhD Oneness Biotech
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