Evaluate the Efficacy and Safety of FB825 in Adult With Allergic Asthma
ConditionAllergic Asthma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorOneness Biotech Co., Ltd.
About this trial
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 criteria
Qualifiers
Male or females 18-75 years old.
Subjects diagnosed with moderate-to-severe allergic asthma [Global Initiative for Asthma [GINA]; GINA, 2021) at least 12 months prior to Visit 1.
Documented reversibility from historical data of at least 12% and 200 mL in FEV1 after the administration of 200 to 400 mcg albuterol/salbutamol (or other standard office practice) OR documented airway hyperresponsiveness (methacholine PC20 < 8 mg/mL [or PC20 < 16 mg/mL on ICS]) OR airflow variability in clinic FEV1 >12% and 200 mL between visits outside of respiratory infections, documented in the past 24 months prior to Visit 1 if documented reversibility and airway hyperresponsiveness data are not available.
Subjects must have a pre-bronchodilator FEV1 value of ≥ 40% and ≤ 80% predicted within 2 months from randomization.
Disqualifiers
Asthma exacerbation or any other reason requiring systemic steroids in the 30 days prior to randomization. Subjects are allowed to be rescreened 30 days after completion of treatment.
>20% relative change in post-bronchodilator FEV1 between screening and randomization.
Female subjects who are pregnant or lactating.
A positive human immunodeficiency virus (HIV) test (e.g., HIV Ag/Ab combo test) at screening or subject taking antiretroviral medications, as determined by medical history.
Trial design
Treatments tested in this trial
- FB825
- Placebo
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Oneness Biotech Co., Ltd.
Lead sponsor
Microbio Shanghai Co., Ltd.
Collaborator
Source ClinicalTrials.gov