Study of CM310 in Patients With Allergic Rhinitis
- Registration Number
- NCT05908721
- Lead Sponsor
- Keymed Biosciences Co.Ltd
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CM310 CM310 Subcutaneous injection
- Primary Outcome Measures
Name Time Method Incidence of adverse events Week 12 Incidence (including number of patients, events and percentage) of adverse events.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Beijing Tong-Ren hospital
🇨🇳Beijing, China