Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients

Inclusion criteria

• . Age ≥ 18 years and ≤ 75 years, no gender restriction;
• . Body weight ≥ 40 kg;
• . Diagnosed with bronchial asthma for at least 1 year according to the "Guidelines for Prevention and Treatment of Bronchial Asthma (2020 Edition)", and diagnosed with allergic asthma according to the "Chinese Guidelines for the Diagnosis and Treatment of Allergic Asthma (2019 Edition)" ; At least 1 asthma exacerbation in the year prior to screening (referring to GINA and Chinese guidelines, asthma exacerbation is defined as worsening of asthma symptoms requiring systemic glucocorticoid treatment for at least 3 days, and/or multiplying the dose of inhaled glucocorticoids for at least 3 days);
• . Positive bronchial dilation test within 24 months prior to screening or at the time of screening;
• . Subjects with at least one positive skin prick test or positive serum specific IgE test result for a relevant allergen within 12 months prior to randomization;
• . Subjects who have received medium to high dose inhaled corticosteroids (ICS) treatment for at least 8 weeks prior to screening (fluticasone propionate \>250 μg/day or equivalent dose of ICS, not exceeding fluticasone propionate 2000 μg/day or equivalent dose of ICS, as per the "Guidelines for Prevention and Treatment of Bronchial Asthma (2020 Edition)"), have maintained stable use for 4 weeks before randomization, with asthma remaining partially controlled or uncontrolled (defined as ACT score ≤ 19);
• . Combined with at least one other asthma control medication (long-acting β2 receptor agonists (LABA), long-acting muscarinic antagonists (LAMA), leukotriene receptor antagonists (LTRA), and sustained-release theophylline treatment) and stable use for 4 weeks before randomization ;