Phase II/III Seamless Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Treatment of Seasonal Allergic Rhinitis
NCT06846385 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2025-04-18
Summary
A multicenter, randomized, double-blind, placebo-controlled Phase II/III seamless clinical study evaluating the efficacy, safety, pharmacokinetic (PK) profile, pharmacodynamic (PD) profile, and immunogenicity of MG-K10 humanized monoclonal antibody injection in the treatment of seasonal allergic rhinitis
Conditions
- Seasonal Allergic Rhinitis
Interventions
- BIOLOGICAL
-
A single dose was administered
- BIOLOGICAL
-
MG-K10 Humanized Monoclonal Antibody Injection
MG-K10 Humanized Monoclonal Antibody Injection
Sponsors & Collaborators
-
Shanghai Mabgeek Biotech.Co.Ltd
lead OTHER_GOV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-20
- Primary Completion
- 2025-05-31
- Completion
- 2025-09-30
Countries
- China
Study Locations
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