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

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Plaque Psoriasis, Healthy Volunteer

In brief

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.

Key facts

Study ID: NCT07038720
Run by: Usynova Pharmaceuticals Ltd.
People needed: 124
Starts: 2025-05-08
Expected to finish: 2026-06-01
Last updated by the study team: 2025-11-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Men and women aged 18-55 at the time of screening visit;
Body mass index (BMI) 18.5-28 kg/m2, inclusive, and total body weight ≥50 kg for male or ≥45 kg for female;
Voluntarily participate in the study and provide the signed and dated informed consent;
For female subjects:
With no childbearing potential, including those who has surgical sterilization (documented tubal ligation, hysterectomy, or bilateral oophorectomy) at least 6 weeks before the screening visit, and who menopause ≥12 months before the screening visit (confirmed by a follicle stimulating hormone (FSH) level ≥40IU/L), or
With childbearing potential (WOCBP), must not be pregnant nor lactating, and must have used nonpharmacologic contraception 30 days before administration, during the study, and for 3 months after dose, and must have tested negative for human chorionic gonadotropin (hCG) at the screening visit and D-1; female subjects must refrain from egg donation during this period.
Males who are sexually active with WOCBP must have used nonpharmacologic contraception 14 days before administration, during the study, and for 3 months after administration. Male subjects must refrain from sperm donation during this time.
Subject is willing to comply with protocol-specified visits, treatments, laboratory tests, and other study-related procedures and requirements.

You may not qualify if…

Allergy to the investigational drugs or the excipients, or a history of severe allergy (including any food allergy or drug allergy);
Has received IL-17 small molecule inhibitors in the past;
Medical history or family history of psychiatric disorders or genetic immunodeficiency;
Has received hematopoietic stem cell transplantation, or organ transplantation in the past;
History of chronic or recurrent infectious diseases, or systemic infection caused by fungal, parasitic or mycotic pathogens, or other opportunistic infections;
History of active or latent tuberculosis (TB), or inadequately treated latent TB infection, or contact history of patients with TB;
Has serious bone or joint infection within 6 months before screening, serious infection (e.g., hospitalization for infection or parenteral antibiotic treatment for infection), or herpes zoster virus infection within 3 months before screening;
Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or treponema pallidum antibody (TP-Ab);
Subject with any acute infection, or any symptoms or signs of infection;
Has presence of a surgical site, trauma site, severe mucosal ulceration, or incomplete fracture healing, or risk of gastrointestinal bleeding/perforation (e.g., active gastroduodenal ulcer, intestinal obstruction, ulcerative colitis, esophagogastric varices, gastrointestinal perforation within 6 months prior to screening), and risk of infection as assessed by the investigator;
Abnormal liver function within 3 months prior to administration, or higher than the upper limit of normal ALT, AST, ALP, or TBL detected during screening period, and is clinically significant;
Has abnormal coagulation parameters (including prothrombin time and international normalized ratio) and is clinically significant;
Known or suspected history of drug abuse (e.g., morphine, methamphetamine, ketamine, dimethylene dioxyamphetamine, THC, cocaine, etc.), or positive at baseline screening for drug abuse;
Alcohol abuse within 1 year prior to screening (drinking more than 14 standard units per week, with 1 standard unit containing 14g of alcohol, such as 360 ml of 5% beer, 45ml of 40% liquor, 120 ml of 12% wine), or positive breath test for alcohol during screening/baseline period;
Smokes more than 5 cigarettes per day or the equivalent of 5 cigarettes per day of nicotine-containing products within 3 months before screening, or inability to comply with the smoking ban during the study;
Has received vaccines within 3 months prior to screening, or plan to receive vaccines during the study;
Has received any experimental drug or participated in any drug/investigational device trial within 3 months before dosing;
Has undergone any surgery in the 3 months prior to screening, or planned to undergo surgery during the study period;
Subject with previous severe or current chronic diseases of the central nervous system, cardiovascular, liver, kidney, lung, digestive tract, metabolic, hematological, skeletal, immune and other systems of clinical significance, or any other diseases or medical conditions that may affect the study or pose an unacceptable risk to the subject in the judgment of the investigator;
History of abdominal surgery affecting the structure and function of the digestive tract;
Subject with structural abnormalities of the digestive tract, or previous history of gastrointestinal disease (such as gastrointestinal bleeding, gastrointestinal perforation, gastroesophageal reflux disease, and inflammatory bowel disease) or current clinically significant gastrointestinal disease (such as gallstones) or symptoms (such as nausea, vomiting, and diarrhea), or patients who had undergone gastrointestinal surgery;
Subject with symptoms of uninduced diarrhea within 3 months prior to screening;
Any clinically significant abnormal results in vital signs, physical examination, or protocol-specified laboratory tests;
Any clinically significant abnormal result in 12-lead ECGs, such as QTcF interval (Fridericia correction) > 450 ms for males and > 470 ms for females;
Serum creatinine clearance (Ccr) < 90 mL/min, calculated according to Cockcroft-Gault formula: Creatinine clearance (mL/min) =(140-age) × body weight (kg) ×(0.85 [women only])/ 72 × serum creatinine (mg/dL), Or creatinine clearance (mL/min) =(140-age) × body weight (kg) ×(0.85 [women only])/ 0.81 × serum creatinine (μmol/L);

Where it is running

Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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