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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ASC50 Tables in Healthy Participants and Participants With Plaque Psoriasis

NCT07024602 · Ascletis Pharma Inc
In plain English

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Official title
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
About this study
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.
Eligibility criteria
Inclusion Criteria: 1. Male and female participants between 18 to 65 years of age inclusive, at the time of screening. 2. Willing and able to give informed consent prior to any study specific procedures being performed. 3. Have venous access sufficient to allow for blood sampling Exclusion Criteria: 1. Female participants who are pregnant, breastfeeding or plan to be pregnant during the study period and 3 months after last dose. 2. History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the subject's safety during the clinical study or expose the subject to undue risk as judged by the Investigator. 3. Have received systemic immunosuppressive therapy (MTX, apremilast, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) within 4 weeks of first administration of study drug. 4. Have any other conditions, which, in the opinion of the investigator or sponsor, would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study.
Study design
Enrollment target: 94 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-06
Estimated completion: 2026-06
Last updated: 2025-06-17
Interventions
Drug: ASC50 tablets or matching placebo
Primary outcomes
  • Adverse Events (Up to Day 7)
  • Adverse Events (Up to Day 43)
Sponsor
Ascletis Pharma (China) Co., Limited · industry
Contacts & investigators
ContactVanessa Wang, MD · contact · global.clinical@ascletis.com · +86 18986192094
All locations (1)
Ascletis Clinical SiteRecruiting
Miami, Florida, United States