NCT06846385

Phase II/III Seamless Clinical Study of MG-K10 Humanized Monoclonal Antibody Injection in Treatment of Seasonal Allergic Rhinitis

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Seamless Clinical Study Evaluating the Efficacy, Safety, PK, PD, and ADA of MG-K10 Humanized Monoclonal Antibody Injection in the Treatment of Seasonal Allergic Rhinitis

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Shanghai Mabgeek Biotech.Co.Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

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. About 120 patients with seasonal allergic rhinitis in stage II and 106 patients with monthly seasonal allergic rhinitis in stage III received only one dose. The study was divided into a screening period (1 week), a double-blind treatment period (4 weeks) and a safety follow-up period (2 weeks).

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	A single dose was administered
BIOLOGICAL	MG-K10 Humanized Monoclonal Antibody Injection	MG-K10 Humanized Monoclonal Antibody Injection

Timeline

• Start date: 2025-03-20
• Primary completion: 2025-05-31
• Completion: 2025-09-30
• First posted: 2025-02-26
• Last updated: 2025-04-18

Locations

1 site across 1 country: China