Study of CM512 in Healthy Subjects and Patients With Atopic Dermatitis

Keymed Biosciences Co.Ltd110 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

110

Conditions

Atopic Dermatitis

Interventions

CM512BIOLOGICAL

CM512 injection

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

Adverse events

Incidence of adverse events.

Time frame: Up to 141 days or up to 169 days

Data from ClinicalTrials.gov

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