FB-825
- Generic Name
- FB-825
- Drug Type
- Biotech
- Unique Ingredient Identifier
- YO4XL7781V
- Background
FB-825 is an investigational humanized monoclonal antibody that targets the CεmX domain of the membrane-bound IgE (mIgE), causing a depletion of mIgE positive B-cells. It is currently being investigated for immune disorders, such as atopic dermatitis and hyperimmunoglobulin E syndrome (HIES).
Evaluate Efficacy and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis
- First Posted Date
- 2024-05-03
- Last Posted Date
- 2025-04-01
- Lead Sponsor
- Oneness Biotech Co., Ltd.
- Target Recruit Count
- 90
- Registration Number
- NCT06397911
- Locations
- 🇺🇸
First OC Dermatology, Fountain Valley, California, United States
🇺🇸California Allergy and Asthma Medical Group, Los Angeles, California, United States
🇺🇸University of California, Davis Health, Department of Dermatology, Sacramento, California, United States
A Study to Evaluate the Safety and Bridging PK Profile of FB825 for Single Subcutaneous Administration in Healthy Adults
Phase 1
Active, not recruiting
- Conditions
- Atopic Dermatitis
- Interventions
- First Posted Date
- 2023-07-19
- Last Posted Date
- 2024-01-26
- Lead Sponsor
- Oneness Biotech Co., Ltd.
- Target Recruit Count
- 22
- Registration Number
- NCT05952986
- Locations
- 🇺🇸
Phase I center, Anaheim, California, United States
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of FB825 in Healthy Volunteers
- First Posted Date
- 2014-12-05
- Last Posted Date
- 2016-02-04
- Lead Sponsor
- Fountain Biopharma Inc.
- Target Recruit Count
- 54
- Registration Number
- NCT02309762
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