Actively Recruiting
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Food Effect of UA026 Tablets in Healthy Adult Subjects and Adult Subjects With Moderate to Severe Plaque Psoriasis
Led by Usynova Pharmaceuticals Ltd. · Updated on 2025-11-17
124
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Study of UA026 Tablets in Healthy Adult Subjects and Adult Subjects With Moderate to Severe Plaque Psoriasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 to 55 years for healthy subjects, and 18 to 70 years for psoriasis patients
- Body mass index (BMI) 18.5-28 kg/m2 for healthy subjects, and 18-35 kg/m2 for psoriasis patients
- Body weight at least 50 kg for healthy males, 45 kg for healthy females, and at least 40 kg for psoriasis patients
- Voluntary participation with signed informed consent
- For females: either no childbearing potential or use of nonpharmacologic contraception as required, with negative pregnancy tests
- For males sexually active with women of childbearing potential: use of nonpharmacologic contraception as required
- Psoriasis patients must have plaque psoriasis diagnosed at least 6 months prior, with stable disease, PASI score ≥12, sPGA score ≥3, and plaques covering at least 10% of body surface area
- Psoriasis patients willing to discontinue other psoriasis treatments except moisturizers or low-intensity topical steroids for salvage therapy
- Willingness to comply with all study procedures and visits
You will not qualify if you...
- Allergy to the investigational drugs or their ingredients
- Previous use of IL-17 small molecule inhibitors
- History or family history of psychiatric disorders or genetic immunodeficiency
- Prior hematopoietic stem cell or organ transplantation
- History of chronic, recurrent, or serious infections including tuberculosis
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis antibodies
- Presence of acute infection or signs of infection
- Recent serious bone, joint, or herpes zoster infections
- Abnormal liver function or coagulation parameters
- History of drug or alcohol abuse
- Smoking more than 5 cigarettes or equivalent per day
- Recent vaccination or participation in other drug trials
- Recent surgery or planned surgery during study
- Significant chronic diseases affecting major organs
- History of gastrointestinal diseases or recent symptoms
- Clinically significant abnormalities in vital signs, physical exam, labs, or ECG
- Low creatinine clearance
- Use of drugs or foods that interfere with liver metabolism or study drug
- Recent blood donation or inability to provide blood samples
- Other conditions posing unacceptable risk as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 56 days
Participants receive UA026 or placebo tablets as part of a drug treatment to evaluate safety, tolerability, and pharmacokinetics.
Multiple visits during dosing and up to 72 hours after last dose
Duration - Up to 56 days after last dose
Participants are monitored for safety and treatment effects after completing dosing.
Follow-up visits for safety assessments
Trial Site Locations
Total: 1 location
1
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
Research Team
Y
Yang Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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