NCT06765005

IB/IIa Study of MG-K10 in Adolescent Moderately Severe Patients

A Phase Ib/II.a Clinical Study of the Safety, Pharmacokinetics and Preliminary Efficacy of MG-K10Humanized Monoclonal Antibody Injection in Adolescent Patients with Moderate to Severe Atopic Dermatitis Aged 12-18 Years.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Shanghai Mabgeek Biotech.Co.Ltd · Industry
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This study was designed to reflect the safety pharmacokinetics and preliminary efficacy of MG-K10 Humanized Monoclonal Antibody Injection in adolescent patients 12-18 weeks of age with moderate to severe atopic dermatitis, administered every 2 or 4 weeks for 8 weeks

Detailed description

Primary Objective: To evaluate the MG-K10 humanized monoclonal antibody injection in adolescent moderate-to-severe atopic dermatitis (AD) patients. Secondary Objective: To evaluate the pharmacokinetic (PK) profile, preliminary efficacy, and safety of MG-K10 humanized monoclonal antibody injection in adolescent patients with moderate-to-severe AD.To assess the pharmacokinetic (PK) profile, preliminary efficacy, pharmacokinetic (PD) profileand immunogenicity.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	MG-K10	Subcutaneous injection, once every 4 weeks

Timeline

• Start date: 2024-07-19
• Primary completion: 2025-05-01
• Completion: 2025-07-01
• First posted: 2025-01-09
• Last updated: 2025-01-09

Locations

1 site across 1 country: China