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

Inclusion criteria

• . 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.
• . Subjects must have received a physician-prescribed asthma regimen with medium- or high-dose ICS plus LABA for at least 3 month prior to Visit 1 and the dose of ICS must be stable for at least 30 days prior to Visit 1 and throughout the screening period.
• . High-dose ICS is defined as total daily dose of \>500 mcg fluticasone propionate or equivalent
• . Medium-dose ICS is defined as a total daily dose of 250 to 500 mcg fluticasone propionate or equivalent.
• . Equivalence ICS doses will be based upon the GINA guidelines (GINA, 2021)

Exclusion criteria