Study of CM310 in Subjects With Allergic Rhinitis
Study of CM310 in Subjects With Allergic Rhinitis
ClinicalTrials.gov ID: NCT05908032
Sponsor: Keymed Biosciences Co.Ltd
Information provided by: Keymed Biosciences Co.Ltd (Responsible Party)
Last Update Posted: 2023-06-18
Brief Summary:
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study aimed at evaluating the efficacy and safety of CM310 in patients with seasonal allergic rhinitis, and observing the quality of life, PK, PD characteristics, and immunogenicity of subjects.
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.
Official Title:
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Patients With Seasonal Allergic Rhinitis Under Background Treatment
Intervention / Treatment:
- Biological: CM310
- Biological: Placebo
| Category | Value |
|---|---|
| Study Start (Estimated) | 2023-09-30 |
| Primary Completion (Estimated) | 2024-05-30 |
| Study Completion (Estimated) | 2024-07-30 |
| Enrollment (Estimated) | 200 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
CM310-107206 |