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Study of CM310 in Subjects With Seasonal Allergic Rhinitis

NCT ID: NCT06171074

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-30

Study Completion Date

2025-03-30

Brief Summary

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This study is a multicenter, single arm phase II clinical study mainly evaluating the efficacy of CM310 in patients with seasonal allergic rhinitis.

Detailed Description

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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.

Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CM310

CM310, Subcutaneous injection

Group Type EXPERIMENTAL

CM310

Intervention Type BIOLOGICAL

CM310 injection

Interventions

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CM310

CM310 injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Keymed Biosciences Co.Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luo Zhang

Role: PRINCIPAL_INVESTIGATOR

Beijing Tong-Ren hospital

Locations

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Beijing Tong-Ren hospital

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Qian Jia

Role: CONTACT

Phone: 028-88610620

Email: [email protected]

Other Identifiers

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CM310-107105

Identifier Type: -

Identifier Source: org_study_id