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
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.
• 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.
• Men and women aged 18-70 at the time of screening visit;
• Body mass index (BMI) 18-35 kg/m2, inclusive, and total body weight ≥ 40 kg;
• Patients with plaque psoriasis who meet the following criteria during screening:
‣ Diagnosis of plaque psoriasis for at least 6 months before the first administration, and, in the opinion of the Investigator, have stable psoriasis with no significant progression or morphological changes.
⁃ Psoriasis Area and Severity Index (PASI) score 12
⁃ Static physician's global assessment (sPGA) ≥3
⁃ Psoriatic plaques must cover 10% of body surface area (BSA)
⁃ Deemed by Investigator to be eligible for phototherapy or systemic therapy
⁃ Subject is willing to discontinue topical and/or systemic therapies other than the investigational drugs, with the exception of topical moisturizer and low-intensity topical steroids used for salvage therapy.
• 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.