Ascletis Clinical Site
Miami, Florida, 33144, United States
Location status: Recruiting
NCT Number: NCT07024602
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 1
Miami, Florida, 33144, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drug: ASC50 administered orally Drug: Placebo administered orally
Time frame: Up to Day 7
Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)
Time frame: Up to Day 43
Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)
Time frame: Up to Day 7
Evaluate the Area under the plasma concentration versus time curve of ASC50
Time frame: Up to Day 34
Evaluate the Area under the plasma concentration versus time curve of ASC50
Time frame: Up to Day 7
Evaluate the Peak Plasma Concentration of ASC50
Time frame: Up to Day 34
Evaluate the Peak Plasma Concentration of ASC50
Time frame: Up to Day 7
Evaluate the Terminal-Phase Half-Life of ASC50
Time frame: Up to Day 34
Evaluate the Terminal-Phase Half-Life of ASC50
Time frame: Up to Day 7
Evaluate the time to reach the maximum concentration of ASC50
Time frame: Up to Day 34
Evaluate the time to reach the maximum concentration of ASC50
Time frame: Up to Day 7
Changes in IL-17A after ASC50 administration
Time frame: Up to Day 29
Changes in IL-17A after ASC50 administration
Time frame: Up to Day 29
Changes in Beta Defensin-2 after ASC50 administration
Time frame: Up to Day 29
Changes in IL-19 after ASC50 administration
Time frame: Up to Day 43
Changes in Psoriasis Area and Severity Index (PASI) after ASC50 treatment.
Time frame: Up to Day 43
Changes in Target Lesion Severity Score (TLSS)after ASC50 treatment.
Contact information is provided by the study sponsor or research team.
Ascletis Pharma (China) Co., Limited
Industry
A Phase I, Randomized, Double-blind, Placebo Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of ASC50 Tablets in Healthy Adult Participants and Adult Participants With Mild to Moderate Plaque Psoriasis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07116967
Plaque Psoriasis
Birmingham, Alabama, United States
View Trial DetailsNCT07683065
Metabolic Dysfunction-Associated Steatotic Liver Disease, Plaque Psoriasis
Badalona, Barcelona, Spain
View Trial DetailsNCT07250802
Plaque Psoriasis
Chula Vista, California, United States
View Trial DetailsNCT06382051
Arthritis, Arthritis, Psoriatic
Calgary, Alberta, Canada
View Trial Details