A Study of UA026 Tablets in Healthy Adult Subjects and Adult Subjects With Moderate to Severe Plaque Psoriasis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUsynova Pharmaceuticals Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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;
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
Disqualifiers
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;
Trial design
Treatments tested in this trial
- UA026
- Placebo
Treatment groups
124 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov