A Study of UA026 Tablets in Healthy Adult Subjects and Adult Subjects With Moderate to Severe Pla… (NCT07038720) | Clinical Trial Compass
RecruitingPhase 1
A Study of UA026 Tablets in Healthy Adult Subjects and Adult Subjects With Moderate to Severe Plaque Psoriasis
China124 participantsStarted 2025-05-08
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. 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.
✓
What they're measuring
1
Number of Participants Experiencing Adverse Events (AEs)
Timeframe: up to 56 days
2
Number of participants with clinically significant changes from baseline in vital signs
Timeframe: up to 56 days
3
Number of participants with clinically significant changes from baseline in clinical laboratory values
Timeframe: up to 56 days
4
Number of participants with clinically significant changes from baseline in physical examination
Timeframe: up to 56 days
5
Number of participants with clinically significant changes from baseline in 12-lead electrocardiograms(ECGs)
. Subject is willing to comply with protocol-specified visits, treatments, laboratory tests, and other study-related procedures and requirements.
Exclusion criteria
✕. 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);