Phase II Trial of RC1416 Injection in Asthma

Inclusion Criteria: * Male or female aged 18 and 75 years. * Diagnosed with asthma for at least 1 year, and the current disease status meets the diagnostic criteria of the 2024 GINA guidelines. * Have received medium-to-high dose ICS therapy for at least 3 consecutive months prior to screening, and maintained a stable treatment regimen and dose for ≥1 month prior to baseline. * Pre-bronchodilator forced expiratory volume in 1 second (FEV1) measurement ≤80% of the predicted normal value at both the screening and baseline visits. * Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5 at both the screening and baseline visits. * Must have experienced ≥1 severe asthma exacerbation event within the 12 months prior to screening. * Positive bronchodilator reversibility test. Exclusion Criteria: * Individuals with a known history of allergy to the investigational product or its excipients. * Clinically diagnosed with chronic obstructive pulmonary disease (COPD) or other lung diseases that may impair lung function . * Experienced a severe asthma exacerbation event from within 1 month prior to screening until before dosing. * Used systemic corticosteroids within 1 month prior to screening. * Had a pulmonary or other site infection requiring intravenous antibiotics, antifungals, or antivirals from within 1 month prior to screening until before dosing. * Used traditional Chinese medicine with anti-asthmatic effects within 1 month prior to screening. * Underwent major surgery within 8 wee…