A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Seamless Clinical Study Evaluating the Efficacy, Safety, PK, PD, and ADA of MG-K10 Humanized Monoclonal Antibody Injection in the Treatment of Seasonal Allergic Rhinitis
A multicenter, randomized, double-blind, placebo-controlled Phase II/III seamless clinical study evaluating the efficacy, safety, pharmacokinetic (PK) profile, pharmacodynamic (PD) profile, and immunogenicity of MG-K10 humanized monoclonal antibody injection in the treatment of seasonal allergic rhinitis
• Age of 18-75 years old (including the cutoff value), male or female;
• With reference to the diagnosis and treatment of allergic rhinitis China guide (2022 revision) subjects conforms to the diagnosis of seasonal allergic rhinitis, history 2 years or more clear, at the same time, at least one over the same period of the current season or allergic rhinitis disease related Skin prick test (Skin Prick Test, SPT) or serum Specific IgE (sIgE) (acceptable within less than 1 year before randomization), and the results met the diagnostic criteria for SAR
• During the previous pollen season, the subjects used nasal corticosteroids or other SAR drugs (antihistamines, leukotriene receptor antagonists, etc.), and their SAR symptoms were poorly controlled.
• The following criteria were met at screening and baseline:
‣ iTNSS score at screening ≥6, nasal congestion ≥2, runny nose, nasal itching, and sneezing 3. One of the symptoms ≥2 points;
⁃ iTNSS score ≥6 at baseline; rTNSS≥6 points, nasal congestion ≥2 points, runny nose, nose,one of the three symptoms of itching and sneezing ≥2 points
• Throughout the study period (from signing the ICF to 6 months after the study drug administration), fertile female subjects and their partners agreed to use highly effective birth control, and male subjects and their partners agreed to use effective birth control and had no plans to donate sperm (men) or eggs (women)
• Be able to understand and comply with clinical protocol requirements, voluntarily participate in clinical trials, and subjects voluntarily sign written informed consent.