A Randomized, Double-blind, Single/Multiple Dose Escalation, Placebo-controlled Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM512 in Healthy Subjects and Patients With Moderate to Severe Atopic Dermatitis
Phase 1
Recruiting
- Conditions
- Moderate to severe atopic dermatitis
- Registration Number
- ChiCTR2400088772
- Lead Sponsor
- West China Hospital of Sichuan University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).<br>Body mass index (BMI) ranges from 18.0 to 26.0 kg/m2 (including boundary values).
Exclusion Criteria
Have participated in any clinical trials of drugs or medical devices within 3 months before the screening.<br>Have severe infections, severe injuries, or undergone major surgical procedures within 3 months before screening.<br>Have lost more than 400 mL of blood due to blood donation or other reasons within 3 months before screening.<br>Positive drug abuse test or positive alcohol breath test result.
Study & Design
- Study Type
- Treatment study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effectiveness evaluation(part C): EASI, IGA, BSA, NRS;Safety Assessment: AE, Physical examination, vital signs, ECG, and laboratory examination ;PK&PD&ADA;
- Secondary Outcome Measures
Name Time Method