Status:
COMPLETED
Study of CM512 in Healthy Subjects and Patients With Atopic Dermatitis
Lead Sponsor:
Keymed Biosciences Co.Ltd
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This is a randomized, double-blind, single/multiple dose escalation, placebo-controlled phase I study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM5...
Eligibility Criteria
Inclusion
- Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
- Body mass index (BMI) ranges from 18.0 to 26.0 kg/m2 (including boundary values).
Exclusion
- Have participated in any clinical trials of drugs or medical devices within 3 months before the screening.
- Have severe infections, severe injuries, or undergone major surgical procedures within 3 months before screening.
- Have lost more than 400 mL of blood due to blood donation or other reasons within 3 months before screening.
- Positive drug abuse test or positive alcohol breath test result.
Key Trial Info
Start Date :
September 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2025
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06553209
Start Date
September 2 2024
End Date
September 12 2025
Last Update
September 22 2025
Active Locations (1)
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1
West China Hospital of Sichuan University
Chengdu, Sichuan, China