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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06553209

Enrollment

110

Registered

2024-08-14

Start date

2024-09-02

Completion date

2025-09-12

Last updated

2025-09-22

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

Conditions

Atopic Dermatitis

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.

Interventions

BIOLOGICALCM512

CM512 injection

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Adverse events	Up to 141 days or up to 169 days	Incidence of adverse events.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026