Study of CM512 in Healthy Subjects and Patients With Atopic Dermatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-02

Study Completion Date

2025-09-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes