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

NCT07038720 | Recruiting Phase 1

• 1 other identifier: UA026-CN101
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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

Plaque Psoriasis; Healthy Volunteer

Outcome Measures

Primary Outcomes (5)

• Number of Participants Experiencing Adverse Events (AEs)

  up to 56 days

• Number of participants with clinically significant changes from baseline in vital signs

  up to 56 days

• Number of participants with clinically significant changes from baseline in clinical laboratory values

  Safety and tolerability outcome measures include, but are not limited to vital signs, physical examination, 12-lead ECGs, clinical laboratory tests, and adverse events.

  up to 56 days

• Number of participants with clinically significant changes from baseline in physical examination

  up to 56 days

• Number of participants with clinically significant changes from baseline in 12-lead electrocardiograms(ECGs)

  up to 56 days

Secondary Outcomes (20)

• Area under the plasma concentration-time curve from time zero to end of dosing interval (AUCtau) for Parts A, B, C and D

  up to 72 hours after the last dose

• Area under the plasma concentration-time curve from time zero to infinity (AUCinf) for Parts A, B, C, and D

  up to 72 hours after the last dose

• Maximum observed plasma concentration (Cmax) for Parts A, B, C and D

  up to 72 hours after the last dose

• Time to maximum plasma concentration (Tmax) for Parts A, B, C and D

  up to 72 hours after the last dose

• Apparent terminal elimination half-life (t½) for Parts A, B, C and D

  up to 72 hours after the last dose

Study Arms (2)

UA026

EXPERIMENTAL

Part A: SAD in healthy subjects Part B: MAD in healthy subjects Part C: FE in healthy subjects Part D: Multiple dose study in psoriasis patients

Drug: UA026

Placebo

PLACEBO COMPARATOR

Part A: SAD in healthy subjects Part B: MAD in healthy subjects Part D: Multiple dose study in psoriasis patients

Drug: Placebo

Interventions

UA026 DRUG

UA026 will be administered as tablet

UA026

Placebo DRUG

Matching placebo will be administered as tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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;

Sponsors & Collaborators

• Usynova Pharmaceuticals Ltd.: lead

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

RECRUITING

Central Study Contacts

Yang Zhang

CONTACT

+86 13636393195; yang_zhang@usynova.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: June 26, 2025
• Study Start: May 8, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-06

Locations

CN (1)