This is a multi-center, randomized, double blind, placebo-controlled multiple dose escalation study to evaluate the safety, tolerance, PK, PD, immunogenicity and preliminary efficacy of subcutaneously CM310 in moderate-severe AD subjects.
The study consists of 3 periods, a up-to-4-week Screening Period, a 4-week randomized Treatment Period and a 8-week Safety Follow-up Period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
39
Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Wuxi Second Hospital
Wuxi, Jiangsu, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Safety parameters (e.g., Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing)
Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Time frame: Baseline to Week 12
Pharmacokinetics parameter: Peak concentration (Cmax)
Peak concentration (Cmax)
Time frame: Baseline to Week 12
Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)
Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)
Time frame: Baseline to Week 12
Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to t (AUC0-t)
Area under the plasma concentration-time curve from 0 to t (AUC0-t)
Time frame: Baseline to Week 12
Pharmacokinetics parameter: Clearance rate (CL/F)
Clearance rate (CL/F)
Time frame: Baseline to Week 12
Pharmacodynamics parameters: Serum Thymus and activation regulated chemokine (TARC)
Serum Thymus and activation regulated chemokine (TARC), total IgE level and blood eosinophil count (EOS)
Time frame: Baseline to Week 12
Pharmacodynamics parameters: Blood eosinophil count (EOS)
Blood eosinophil count (EOS)
Time frame: Baseline to Week 12
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Peking University People's Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Shanghai Skin Disease Hospital
Shanghai, China
Pharmacodynamics parameters: Total IgE level
Total IgE level
Time frame: Baseline to Week 12
Immunogenicity: Proportion of subjects with anti-drug antibody (ADA)
Proportion of Participants with anti-drug antibody (ADA)
Time frame: Baseline to Week 12
Preliminary efficacy: Proportion of subjects with IGA 0 or 1
Proportion of subjects with Investigator's Global Assessment (IGA, on a 6-point scale, range from 0-5 point, higher scores mean a worse disease severity) 0 or 1
Time frame: Baseline to Week 12
Preliminary efficacy: Proportion of subjects with a reduction of IGA from baseline of ≥ 2 points
Proportion of subjects with a reduction of IGA from baseline of ≥ 2 points
Time frame: Baseline to Week 12
Preliminary efficacy: Proportion of subjects with IGA 0 or 1 and a reduction of IGA from baseline of ≥ 2 points
Proportion of subjects with IGA 0 or 1 and a reduction of IGA from baseline of ≥ 2 points
Time frame: Baseline to Week 12
Preliminary efficacy: Proportion of subjects with EASI-50
Proportion of subjects with The Eczema Area and Severity Index(EASI)-50 (≥50 percent improvement from baseline)
Time frame: Baseline to Week 12
Preliminary efficacy: Proportion of subjects with EASI-75
Proportion of subjects with EASI-75 (≥75 percent improvement from baseline)
Time frame: Baseline to Week 12
Preliminary efficacy: Proportion of subjects with improvement (reduction) of pruritus NRS from baseline
Proportion of subjects with improvement (reduction) of pruritus Numerical Rating Scale(NRS) from baseline; The range of NRS is from 0 (no itch)-10 (worst imaginable itch)
Time frame: Baseline to Week 12