NCT05059509

Evaluate Efficacy of FB825 in Adults With Atopic Dermatitis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Oneness Biotech Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is an open labeled exploratory study to evaluate efficacy of FB825 in adults with atopic dermatitis (AD). The study will be conduct at one medical center in Taiwan. Approximately 20 subjects with atopic dermatitis (AD), who meet the criteria for study entry, will be enrolled to the study. All eligible subjects will receive FB825, 5mg/kg, by 1 hour IV infusion on Day 1. Subjects will return to the study site on Days 15, 29 and 57 for the safety and efficacy evaluation. Subjects who premature withdraw from the study will have an end of study (EOS) visit within 7 days.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
BIOLOGICAL	FB825	FB825, 5mg/kg, by 1 hour IV infusion on Day 1

Timeline

• Start date: 2020-02-06
• Primary completion: 2021-05-10
• Completion: 2022-03-31
• First posted: 2021-09-28
• Last updated: 2022-04-04

Locations

1 site across 1 country: Taiwan