The purpose of this Phase 1 study is to evaluate the safety and tolerability of a new investigational drug called SSGJ-716 in healthy adults and in participants with moderate-to-severe atopic dermatitis (AD). The study has two parts. The first part (Single Ascending Dose, SAD) will enroll healthy adults.The second part (Multiple Ascending Dose, MAD) will enroll participants with moderate-to-severe AD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
Huashan Hospital, Fudan University
Shanghai, China
RECRUITINGNumber of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: 85 days
Maximum observed concentration (Cmax)
Time frame: 85 days
Time to maximum concentration (Tmax)
Time frame: 85 days
Elimination half-life (t1/2)
Time frame: 85 days
Area under the concentration-time curve from time zero to last measurable concentration (AUC0-last)
Time frame: 85 days
Incidence of Anti-Drug Antibody (ADA)
Time frame: 85 days
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