Allergic Rhinitis
Conditions
Brief summary
This study is a multicenter, single arm, open-label phase II clinical study mainly evaluating the safety of CM310 in patients with allergic rhinitis.
Detailed description
Allergic rhinitis (AR) is a non infectious chronic inflammatory disease of the nasal mucosa that is mainly mediated by immunoglobulin E (IgE) in atopic individuals exposed to allergens.
Interventions
BIOLOGICALCM310
IL-4Rα monoclonal antibody
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18-65. * Understand the study and sign the Informed Consent Form voluntarily. * Take effective contraception measures throughout the study period.
Exclusion criteria
* Used other investigational drugs. * Allergies to drugs with IL-4Rα monoclonal antibody or drug components of CM310. * Plan to participate in other studies during this clinical trial. * With malignant or benign tumors of the nasal cavity. * Other reasons the researcher believes that the subject is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | Week 12 | Incidence (including number of patients, events and percentage) of adverse events. |
Countries
China
Outcome results
None listed