This is a randomized, double-blind phase II clinical study to evaluate the efficacy and safety of AK139 in the treatment of participants with moderate to severe asthma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Shanghai General Hospital
Shanghai, China
Absolute change from baseline in pre-bronchodilator FEV1
Time frame: Up to week 12
Absolute change and percent change from baseline in FENO
Time frame: Up to week 12
Adverse events (AEs), serious adverse events(SAEs)
Time frame: Up to week 4
Serum AK139 concentration
Time frame: Up to week 20
Immunogenicity characteristics of AK139
Number of participants with detectable anti-drug antibodies (ADA) and neutralizing antibodies (Nab) after treatment.
Time frame: Up to week 20
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subcutaneous injection.