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NCT05908721 Clinical Trial

Study of CM310 in Patients With Allergic Rhinitis

Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05908721
Other study ID # CM310-107107
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date October 30, 2023
Est. completion date October 30, 2024

Study information
Verified date June 2023
Source Keymed Biosciences Co.Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date October 30, 2024
Est. primary completion date October 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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-4Ra 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

Related Conditions & MeSH terms

Intervention

Biological:
• CM310
IL-4Ra monoclonal antibody

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Keymed Biosciences Co.Ltd

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of adverse events Incidence (including number of patients, events and percentage) of adverse events. Week 12
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