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Clinical Trials/NCT05579925
NCT05579925
Completed
Phase 2

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

Keymed Biosciences Co.Ltd1 site in 1 country24 target enrollmentOctober 7, 2022
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ConditionsAtopic Dermatitis
InterventionsCM310
DrugsCM310

Overview

Phase
Phase 2
Intervention
CM310
Conditions
Atopic Dermatitis
Sponsor
Keymed Biosciences Co.Ltd
Enrollment
24
Locations
1
Primary Endpoint
Adverse events
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 7, 2022
End Date
July 28, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Keymed Biosciences Co.Ltd
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

CM310

600 mg + 300 mg, subcutaneous injection, once every two weeks

Intervention: CM310

Outcomes

Primary Outcomes

Adverse events

Time Frame: at week 14

Incidence of adverse events.

Study Sites (1)

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