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Study of CM310 in Patients With Allergic Rhinitis

Sponsor
Keymed Biosciences Co.Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05908721
Collaborator
(none)
100
Enrollment
1
Arm
12
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: CM310
 Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Oct 30, 2023
Anticipated Primary Completion Date :
Oct 30, 2024
Anticipated Study Completion Date :
Oct 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: CM310

Subcutaneous injection

Biological: CM310
IL-4Rα monoclonal antibody

Outcome Measures

Primary Outcome Measures

  1. Incidence of adverse events [Week 12]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Keymed Biosciences Co.Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Keymed Biosciences Co.Ltd
ClinicalTrials.gov Identifier:
NCT05908721
Other Study ID Numbers:
  • CM310-107107
First Posted:
Jun 18, 2023
Last Update Posted:
Jun 18, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic

Study Results

No Results Posted as of Jun 18, 2023