This is a randomized, double-blind, placebo-controlled phase I study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of SKB575. This study consists of two parts. Phase Ia is a single ascending dose study in healthy subjects and Phase Ib is a proof-of-concept study in patients with moderate to severe atopic dermatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Pharmaceutical form: Solution for injection in vial Route of administration: Subcutaneous injection
Huashan Hospital Affiliated to Fudan University
Shanghai, China
RECRUITINGHuashan Hospital Affiliated to Fudan University
Shanghai, China
RECRUITINGNumber of participants with adverse events (AEs) /TEAEs
Incidence of adverse events (AEs) and treatment-emergent adverse events (TEAEs)
Time frame: From Baseline to Day 225
Proportion of participants achieving EASI-75 at Week 16
EASI 75 is defined by reduction of EASI score by ≥75% from baseline
Time frame: From Baseline throughout the study, up to Week 16
Pharmacokinetic (PK) assessment: Cmax
Maximum plasma concentration
Time frame: From baseline to Day 225
Pharmacokinetic (PK) assessment: Tmax
Time to reach Cmax
Time frame: From baseline to Day 225
Pharmacokinetic (PK) assessment: AUClast
Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration
Time frame: From baseline to Day 225
Presence of Anti-SKB575 Antibodies (ADA)
Positive rate of participant with SKB575 antibodies
Time frame: From baseline to Day 225
Pharmacodynamic (PD) Characteristics: Eosinophil
Change from baseline in total serum target concentrations of eosinophil
Time frame: From baseline to Day 225
Pharmacodynamic (PD) Characteristics: IgE
Change from baseline in total serum target concentrations of IgE
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Time frame: From baseline to Day 225
Pharmacodynamic (PD) Characteristics: TARC
Change from baseline in total serum target concentrations of TARC
Time frame: From baseline to Day 225