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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

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088772
Enrollment
Unknown
Registered
2024-08-27
Start date
2024-08-27
Completion date
Unknown
Last updated
2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe atopic dermatitis

Interventions

Experimental Group :CM512 subcutaneous injection
Placebo Group:Placebo subcutaneous injection

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Effectiveness evaluation(part C): EASI, IGA, BSA, NRS;Safety Assessment: AE, Physical examination, vital signs, ECG, and laboratory examination ;PK&PD&ADA;—

Countries

China

Contacts

Public ContactPing feng

West China Hospital of Sichuan University

617130961@qq.com+86 189 8060 6320

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026