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NCT06162507 Clinical Trial

Study of CM310 in Children Subjects 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 Children Subjects With Moderate-to-severe Atopic Dermatitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06162507
Other study ID # CM310-101010
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 30, 2024
Est. completion date March 30, 2025

Study information
Verified date November 2023
Source Keymed Biosciences Co.Ltd
Contact n/a
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 in children patients with moderate-to severe atopic dermatis.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 24
Est. completion date March 30, 2025
Est. primary completion date March 30, 2025
Accepts healthy volunteers No
Gender All
Age group 6 Years to 11 Years
Eligibility Inclusion Criteria: - With atopic dermatis. - Voluntarily sign the informed consent form. Exclusion Criteria: - Any major surgery planned during the research period. - With intestinal parasitic infection within the first 6 months of screening. - With any previous malignant tumors prior to screening. - With any circumstance that is not suitable to participate in this study.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• CM310
CM310 injection

Locations
Country Name City State
n/a

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

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events Incidence of adverse events. up to week 16
See also
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