A Phase IIb Study of 610 in Participants With Severe Eosinophilic Asthma

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase IIb, Effcacy and Safety Study of Recombinant Anti-IL-5 Humanized Monoclonal Antibody Therapy in Adult Subjects With Severe Asthma

This study will assess the effcacy and safety of 610 as an adjunctive therapy in adult subjects with severe eosinophilic asthma.

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the effcacy and safety of 610 in adults with severe eosinophilic asthma. Subjects divided into 3 groups: A group,B group and placebo group. The study is divided into screening period of 4 weeks, treatment period of 16 weeks, prolonged treatment period of 36 weeks and follow-up period of 8 weeks.

Inclusion Criteria:

• 1. Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study.
• 2. Female and male aged 18 to 75 years.
• 3. Diagnosed with asthma for ≥12 months that meet GINA.
• 4. History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.
• 5. Documented history of ≥ 1 moderate exacerbations within 12 months prior to screening.
• 6. Asthma Control Questionnaire question version (ACQ) score ≥1.5 at the screening visit and the randomization visit.

Exclusion Criteria:

• 1. Presence of a known pre-existing, clinically important lung condition other than Asthma.
• 2. Severe asthma exacerbation within 4 weeks prior to randomization.
• 3. Subjects with any eosinophilic diseases other than asthma.
• 4. Known, pre-existing severe or clinically significant cardiovascular disease.
• 5. known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment.
• 6. Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
• 7. Subjects with allergy/intolerance to a monoclonal antibody.