Study of CM512 in Healthy Subjects and Patients With Atopic Dermatitis

September 16, 2025 updated by: Keymed Biosciences Co.Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital of Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 2
Drug: Placebo
Placebo
Biological: CM512
CM512 injection
Experimental: Group 1
Drug: Placebo
Placebo
Biological: CM512
CM512 injection
Experimental: Group 3
Drug: Placebo
Placebo
Biological: CM512
CM512 injection
Experimental: Group 4
Drug: Placebo
Placebo
Biological: CM512
CM512 injection
Experimental: Group 5
Drug: Placebo
Placebo
Biological: CM512
CM512 injection
Experimental: Group 6
Drug: Placebo
Placebo
Biological: CM512
CM512 injection
Experimental: Group 7
Drug: Placebo
Placebo
Biological: CM512
CM512 injection

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keymed Biosciences Co.Ltd

Investigators

  • Principal Investigator: Jingyi Li, West China Hospital
  • Principal Investigator: Ping Feng, West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2024

Primary Completion (Actual)

August 26, 2025

Study Completion (Actual)

September 12, 2025

Study Registration Dates

First Submitted

August 11, 2024

First Submitted That Met QC Criteria

August 11, 2024

First Posted (Actual)

August 14, 2024

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM512-100001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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