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.
iTNSS score at screening ≥6, nasal congestion ≥2, runny nose, nasal itching, and sneezing 3. One of the symptoms ≥2 points;
Allergy to the study drug or its excipients;
Travel plans for 48 hours or more from known pollen areas during the screening/induction and treatment periods (visit 5);
The subject's exposure to allergens in his or her home or work environment may have changed significantly during the trial, which the investigator determines may affect the efficacy evaluator;
Subjects with limited outdoor activities during the day were defined as those who did not have any outdoor activities during the day for 1 or 4 days per week.