NCT06162507
Completed
Phase 1
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
Keymed Biosciences Co.Ltd1 site in 1 country24 target enrollmentDecember 22, 2023
Overview
- Phase
- Phase 1
- Intervention
- CM310
- Conditions
- Atopic Dermatitis
- Sponsor
- Keymed Biosciences Co.Ltd
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Adverse events
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a multi-center, single arm, open-label study to evaluate safety in children patients with moderate-to severe atopic dermatis.
Investigators
Eligibility Criteria
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.
Arms & Interventions
CM310 group A
CM310 injection, subcutaneous injection, once every 3 weeks.
Intervention: CM310
CM310 group B
CM310 injection, subcutaneous injection, once every 2 weeks.
Intervention: CM310
Outcomes
Primary Outcomes
Adverse events
Time Frame: up to week 16
Incidence of adverse events.
Study Sites (1)
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