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Study of CM512 in Healthy Subjects and Patients With Atopic Dermatitis

K

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

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

Trial contacts and locations

1

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Central trial contact

Qian Jia

Data sourced from clinicaltrials.gov

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