This study is a multicenter, randomized, double-blind, placebo-controlled phase Ib study to evaluate the safety, tolerability, efficacy, PK/PD characteristics, and immunogenicity of SKB575 (HBM7575) injection in subjects with asthma.
The participant is able to understand and comply with the requirements of this study, and voluntarily signs the informed consent form.
Aged between 18 and 70 years inclusive at the time of signing the informed consent form, with no restriction on gender.
Body Mass Index (BMI) shall be ≥ 18.0 kg/m² and ≤ 32.0 kg/m².
Diagnosis of asthma consistent with the Global Initiative for Asthma (GINA) 2025 diagnostic criteria.
Within 3 months prior to randomization, the participant experienced an acute asthma exacerbation requiring continuous systemic corticosteroid therapy for ≥3 consecutive days, or presented to the emergency department or was hospitalized due to asthma with administration of systemic corticosteroids (calculated from the completion date of treatment for the asthma exacerbation).
Known hypersensitivity to the investigational product or its excipients, or a history of allergic reactions to any biological products.
Concomitant clinically significant pulmonary diseases, including but not limited to pulmonary infection, chronic obstructive pulmonary disease (COPD), bronchiectasis, interstitial lung disease, pulmonary vascular disease, pulmonary neoplasm, or any other diseases affecting pulmonary function other than asthma.
Concomitant diseases that may impair pulmonary function, including but not limited to clinically significant pleural disorders, mediastinal diseases, diaphragmatic lesions, myasthenia, thoracic deformities, etc.