This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, food effect of ASC50 tablets in healthy adult participants and adult participants with mild to moderate plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
94
Drug: ASC50 administered orally Drug: Placebo administered orally
Ascletis Clinical Site
Miami, Florida, United States
RECRUITINGAdverse Events
Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)
Time frame: Up to Day 7
Adverse Events
Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)
Time frame: Up to Day 43
AUC
Evaluate the Area under the plasma concentration versus time curve of ASC50
Time frame: Up to Day 7
AUC
Evaluate the Area under the plasma concentration versus time curve of ASC50
Time frame: Up to Day 34
Cmax
Evaluate the Peak Plasma Concentration of ASC50
Time frame: Up to Day 7
Cmax
Evaluate the Peak Plasma Concentration of ASC50
Time frame: Up to Day 34
T1/2
Evaluate the Terminal-Phase Half-Life of ASC50
Time frame: Up to Day 7
T1/2
Evaluate the Terminal-Phase Half-Life of ASC50
Time frame: Up to Day 34
Tmax
Evaluate the time to reach the maximum concentration of ASC50
Time frame: Up to Day 7
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Tmax
Evaluate the time to reach the maximum concentration of ASC50
Time frame: Up to Day 34
IL-17A
Changes in IL-17A after ASC50 administration
Time frame: Up to Day 7
IL-17A
Changes in IL-17A after ASC50 administration
Time frame: Up to Day 29
Beta Defensin-2
Changes in Beta Defensin-2 after ASC50 administration
Time frame: Up to Day 29
IL-19
Changes in IL-19 after ASC50 administration
Time frame: Up to Day 29
Psoriasis Area and Severity Index (PASI)
Changes in Psoriasis Area and Severity Index (PASI) after ASC50 treatment.
Time frame: Up to Day 43
Target Lesion Severity Score (TLSS)
Changes in Target Lesion Severity Score (TLSS)after ASC50 treatment.
Time frame: Up to Day 43