Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-31 @ 2:08 PM
Study NCT ID:
NCT06765005
Status:
RECRUITING
Last Update Posted:
2025-01-09
First Post:
2024-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IB/IIa Study of MG-K10 in Adolescent Moderately Severe Patients
Sponsor:
Shanghai Mabgeek Biotech.Co.Ltd
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: