RecruitingPhase 2NCT05008965

Evaluate the Efficacy and Safety of FB825 in Adult With Allergic Asthma

A Phase II Study to Evaluate the Efficacy and Safety of FB825 in Adult Patients With Moderate-to-severe Allergic Asthma


Sponsor

Oneness Biotech Co., Ltd.

Enrollment

100 participants

Start Date

Jul 27, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is a randomized, placebo-controlled and double-blind study to evaluate the efficacy and safety of FB825 in adult patients with moderate-to-severe allergic asthma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called FB825 in adults with moderate-to-severe allergic asthma — the kind caused by allergen triggers — to evaluate its safety and effectiveness at controlling asthma symptoms. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with moderate-to-severe allergic asthma for at least 12 months - Your asthma symptoms reverse or react to standard testing (such as a bronchodilator or methacholine challenge) - Your lung function (FEV1) is at or above 40% of the expected value before using an inhaler **You may NOT be eligible if...** - Your asthma is not allergy-triggered - Your asthma has not been confirmed as moderate-to-severe - Your lung function is too impaired - You have other significant lung or immune conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFB825

FB825 will be administered at 8 mg/kg for the first dose and 4 mg/kg for the other five doses.

DRUGPlacebo

Placebo will be administered at 8 mg/kg for the first dose and 4 mg/kg for the other five doses.


Locations(13)

Kaohsiung Chang Gung Medical Foundation

Kaohsiung City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Far Eastern Memorial Hospital

New Taipei City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Taichung Venterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Linkou Chang Gung Memorial Hospital

Taipei, Taiwan

MacKay Memorial Hospital

Taipei, Taiwan

Ministry of Health and Welfare Shuang-Ho Hospital

Taipei, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Taipei Municipal Wanfang Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT05008965


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