A Phase Ib/II Study to Investigate the Safety、PK and PD of SHR-1819 in Children and Adolescents With Moderate-to-severe Atopic Dermatitis
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This trial was designed to evaluate the safety of SHR-1819 in children and adolescents with moderate-to-severe atopic dermatitis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 18
Healthy Volunteers: f
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• Subjects and their parents or legal guardians have voluntarily signed the informed consent form prior to the start of any procedures related to the study, are able to communicate smoothly with the investigator, understand and are willing to strictly comply with the requirements of this clinical study protocol to complete the study;
• At the time of signing the informed consent, the subjects were ≥ 6 years old and \< 18 years old, male or female;
• Have atopic dermatitis at screening.
Locations
Other Locations
China
The First Affiliated Hospital of China Medical University
RECRUITING
Shenyang
Contact Information
Primary
Xiaoyan Bai
xiaoyan.bai.xb1@hengrui.com
0518-82342973
Time Frame
Start Date: 2024-12-18
Estimated Completion Date: 2025-12
Participants
Target number of participants: 50
Treatments
Experimental: SHR-1819 injection
Dose 1, dose 2 and dose 3.
Related Therapeutic Areas
Sponsors
Leads: Guangdong Hengrui Pharmaceutical Co., Ltd