Phase 1 Study of UA026 Tablets to Assess Safety, Tolerability, and Effects in Healthy Adults and Adults With Moderate to Severe Plaque Psoriasis

What this Trial Is About

Researchers are evaluating UA026 tablets in a randomized, double-blind, placebo-controlled study to assess their safety, tolerability, pharmacokinetics, and the effect of food on the medication. The study includes healthy adults and adults with moderate to severe plaque psoriasis. UA026 is a small molecule designed to inhibit IL-17A, a protein involved in inflammation and psoriasis symptoms. This first-in-human Phase I trial aims to understand how the drug behaves in the body and its impact on biomarkers related to psoriasis. The study has four parts Part A tests single ascending doses in healthy subjects Part B evaluates multiple ascending doses in healthy subjects Part C explores the effect of food on the medication in healthy subjects and Part D studies multiple doses in patients with moderate to severe plaque psoriasis. Participants will receive either UA026 tablets or matching placebo tablets, with dosing and schedules varying by study part. Parts A, B, and C involve healthy volunteers, while Part D enrolls psoriasis patients. Participants will attend visits for treatment administration and monitoring over periods up to 56 days or longer depending on the study part. Researchers will assess safety by tracking adverse events, vital signs, lab tests, physical exams, and heart monitoring ECGs. They will also measure drug levels in blood and changes in psoriasis severity using tools like PASI and sPGA scores. The study includes careful follow-up for safety and drug effects, with total participation time depending on the study segment enrolled.

A Study of UA026 Tablets in Healthy Adult Subjects and Adult Subjects With Moderate to Severe Plaque Psoriasis