Study of CM512 in Healthy Subjects and Patients With Atopic Dermatitis
Phase 1
Not yet recruiting
- Conditions
- Atopic Dermatitis
- Interventions
- Biological: CM512Drug: Placebo
- Registration Number
- NCT06553209
- Lead Sponsor
- Keymed Biosciences Co.Ltd
- 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 CM512 in healthy subjects and patients with moderate to severe atopic dermatitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 94
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 CM512 - Group 3 CM512 - Group 5 Placebo - Group 6 CM512 - Group 1 CM512 - Group 1 Placebo - Group 2 Placebo - Group 6 Placebo - Group 7 Placebo - Group 4 CM512 - Group 4 Placebo - Group 7 CM512 - Group 3 Placebo - Group 5 CM512 -
- Primary Outcome Measures
Name Time Method Adverse events Up to 141 days or up to 169 days Incidence of adverse events.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China