Actively Recruiting
A Study 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
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetic profile, and food effect of UA026 tablets. The study consists of four parts: Part A is a single ascending dose (SAD) study, Part B is a multiple ascending dose (MAD) study, Part C is a food effect (FE) study, and Part D is a multi-dose parallel control study. Part A, B, and C will be conducted in healthy subject, and Part D will be conducted in subjects with moderate to severe plaque psoriasis.
CONDITIONS
Official 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 18-55 years (healthy subjects) or 18-70 years (psoriasis patients) at screening
- BMI 18.5-28 kg/m2 (healthy subjects) or 18-35 kg/m2 (psoriasis patients)
- Body weight ≥50 kg for males or ≥45 kg for females (healthy subjects), or ≥40 kg (psoriasis patients)
- Healthy subjects must voluntarily participate and provide signed informed consent
- Female subjects with no childbearing potential must have surgical sterilization or menopause ≥12 months confirmed by FSH level ≥40 IU/L
- Female subjects with childbearing potential must not be pregnant or lactating, use nonpharmacologic contraception 30 days before, during, and 3 months after dosing, and test negative for hCG at screening
- Male subjects sexually active with women of childbearing potential must use nonpharmacologic contraception 14 days before, during, and 3 months after dosing
- Psoriasis patients must have diagnosis of plaque psoriasis for at least 6 months with stable disease
- Psoriasis patients must have PASI score ≥12, static physician's global assessment score ≥3, and psoriatic plaques covering ≥10% body surface area
- Psoriasis patients must be eligible for phototherapy or systemic therapy and willing to discontinue other therapies except topical moisturizer or low-intensity steroids
- Willingness to comply with study visits, treatments, laboratory tests, and procedures
You will not qualify if you...
- Allergy to investigational drugs or excipients, or history of severe allergies
- Prior use of IL-17 small molecule inhibitors
- Medical or family history of psychiatric disorders or genetic immunodeficiency
- History of hematopoietic stem cell or organ transplantation
- History of chronic, recurrent, or systemic infections including fungal, parasitic, or opportunistic infections
- History of active or latent tuberculosis or exposure to tuberculosis patients
- Recent serious infections or herpes zoster virus infection
- Positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or treponema pallidum antibody
- Acute infection or symptoms/signs of infection
- Presence of surgical or trauma sites, severe mucosal ulcers, incomplete fracture healing, or gastrointestinal bleeding/perforation risk
- Abnormal liver function or coagulation parameters clinically significant
- Known or suspected drug abuse
- Alcohol abuse or heavy smoking history
- Recent vaccination or participation in other drug/investigational device trials
- Recent surgery or planned surgery during study
- Severe or chronic diseases affecting major organ systems or clinical judgment risks
- Structural abnormalities or significant gastrointestinal diseases or symptoms
- Clinically significant abnormal vital signs, physical exams, laboratory tests, or ECG results
- Reduced creatinine clearance below specified thresholds
- Recent use of drugs interacting with investigational drug or affecting liver metabolism
- Inability to comply with medication restrictions or venipuncture requirements
- Recent blood donation or loss ≥400 ml
- Other serious systemic diseases or abnormalities posing unacceptable risk as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
Research Team
Y
Yang Zhang
CONTACT
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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