Study of CM512 in Healthy Subjects and Patients With Atopic Dermatitis
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
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2024
CompletedFirst Posted
Study publicly available on registry
August 14, 2024
CompletedStudy Start
First participant enrolled
September 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 12, 2025
CompletedSeptember 22, 2025
September 1, 2025
12 months
August 11, 2024
September 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events
Incidence of adverse events.
Up to 141 days or up to 169 days
Study Arms (7)
Group 1
EXPERIMENTALGroup 2
EXPERIMENTALGroup 3
EXPERIMENTALGroup 4
EXPERIMENTALGroup 5
EXPERIMENTALGroup 6
EXPERIMENTALGroup 7
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West China Hospital of Sichuan University
Chengdu, Sichuan, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jingyi Li
West China Hospital
- PRINCIPAL INVESTIGATOR
Ping Feng
West China Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2024
First Posted
August 14, 2024
Study Start
September 2, 2024
Primary Completion
August 26, 2025
Study Completion
September 12, 2025
Last Updated
September 22, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share