A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Subjects With Moderate to Severe Asthma

CM310-CSP-001

This study is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy, safety, PK characteristics, PD effects and immunogenicity of CM310 in subjects with moderate to severe asthma. The study consists of three periods, including an up to 4-week screening period, a 24-week randomized treatment period, and a 8-week safety follow-up period.

2022-01-12

2023-09-13

2023-09-13

Completed

Early phase I

52

Inclusion Criteria: * Subjects are able to understand the nature of the study and voluntarily sign the ICF. * Diagnosed with asthma according to the 2021 version of the GINA guidelines for at least 1 year. * Pre-bronchodilator FEV1 measurement ≤ 80% of predicted normal value. * Subjects must have experienced a severe asthma exacerbation within 12 months prior to screening, and have not experienced a severe asthma exacerbation within 1 month prior to screening. Exclusion Criteria: * Women of childbearing potential have a positive pregnancy test result during the screening period; women who are pregnant or lactating. * Received biologics with the same therapeutic purpose within 6 months prior to screening, such as similar IL-4Rα antagonist, IL-5/5R, anti-IgE monoclonal antibody (mAb). * Diagnosed with chronic obstructive pulmonary disease (COPD) or other lung disorders that may compromise lung function (including but not limited to idiopathic pulmonary fibrosis, allergic granulomatous angiitis, bronchopulmonary aspergillosis allergic, pulmonary tuberculosis, etc.).

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2024-02-28