Study of CM310 in Patients With Allergic Rhinitis

Keymed Biosciences Co.Ltd100 enrolled

Overview

This study is a multicenter, single arm, open-label phase II clinical study mainly evaluating the safety of CM310 in patients with allergic rhinitis.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Allergic Rhinitis

Interventions

CM310BIOLOGICAL

IL-4Rα monoclonal antibody

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Tong-Ren hospital

Beijing, China

Outcomes

Primary Outcomes

Incidence of adverse events

Incidence (including number of patients, events and percentage) of adverse events.

Time frame: Week 12

Data from ClinicalTrials.gov

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