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NCT05579925 Clinical Trial

A Study of CM310 in Children Patients With Moderate-to-severe Atopic Dermatis

Atopic Dermatitis Clinical Trial

Official title:
A Multicenter, Single-arm, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacokinetics of CM310 in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05579925
Other study ID # CM310-101108
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 7, 2022
Est. completion date October 30, 2023

Study information
Verified date October 2022
Source Keymed Biosciences Co.Ltd
Contact Qian Jia
Phone 028-88610620
Email qianjia@keymedbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multi-center, single arm, open-label study to evaluate safety and primary efficacy in children patients with moderate-to severe atopic dermatis.

Recruitment information / eligibility
Status Recruiting
Enrollment 24
Est. completion date October 30, 2023
Est. primary completion date October 30, 2023
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria: - 12 years = age = 18 years - With atopic dermatis - Voluntarily sign the informed consent form Exclusion Criteria: - Weight < 30 kg - Major surgery planed during the study

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• CM310
CM310 600 mg + 300 mg, subcutaneous injection

Locations
Country Name City State
China Beijing Children's Hospital Capital Medical University Beijing

Sponsors (1)
Lead Sponsor Collaborator
Keymed Biosciences Co.Ltd

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events Incidence of adverse events. at week 14
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