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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06162507
Enrollment
24
Registered
2023-12-08
Start date
2023-12-22
Completion date
2024-07-04
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Brief summary

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

Interventions

BIOLOGICALCM310

CM310 injection

Sponsors

Keymed Biosciences Co.Ltd
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Adverse eventsup to week 16Incidence of adverse events.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026