A Multicenter, Single Arm Phase II Clinical Study Evaluating the Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Patients With Seasonal Allergic Rhinitis

Keymed Biosciences Co.Ltd1 site in 1 country100 target enrollmentAugust 23, 2023

ConditionsAllergic Rhinitis

InterventionsCM310

DrugsCM310

Overview

Phase: Phase 2
Intervention: CM310
Conditions: Allergic Rhinitis
Sponsor: Keymed Biosciences Co.Ltd
Enrollment: 100
Locations: 1
Primary Endpoint: Incidence of adverse events
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 23, 2023

End Date

December 10, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Keymed Biosciences Co.Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female aged 18-
•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 CM
•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.