Study of CM512 in Healthy Subjects and Patients With Atopic Dermatitis

Keymed Biosciences

Status and phase: Begins enrollment this month; Phase 1

Conditions: Atopic Dermatitis

Treatments: Biological: CM512; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06553209

CM512-100001

Details and patient eligibility

About

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.

Enrollment: 94 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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94 participants in 7 patient groups

Group 1

Experimental group

Treatment:

Drug: Placebo

Biological: CM512

Group 2

Experimental group

Treatment:

Drug: Placebo

Biological: CM512

Group 3

Experimental group

Treatment:

Drug: Placebo

Biological: CM512

Group 4

Experimental group

Treatment:

Drug: Placebo

Biological: CM512

Group 5

Experimental group

Treatment:

Drug: Placebo

Biological: CM512

Group 6

Experimental group

Treatment:

Drug: Placebo

Biological: CM512

Group 7

Experimental group

Treatment:

Drug: Placebo

Biological: CM512