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

ConditionsPlaque PsoriasisHealthy Volunteer
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

This trial accepts healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • UA026

    Drug

    UA026 will be administered as tablet

  • Placebo

    Drug

    Matching placebo will be administered as tablet

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: UA026Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants Experiencing Adverse Events (AEs)

Time frame
up to 56 days
2

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

Time frame
up to 56 days
3

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.

Time frame
up to 56 days
4

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

Time frame
up to 56 days

Secondary outcomes

1

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

Time frame
up to 72 hours after the last dose
2

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

Time frame
up to 72 hours after the last dose
3

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

Time frame
up to 72 hours after the last dose
4

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

Time frame
up to 72 hours after the last dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Usynova Pharmaceuticals Ltd.

Lead sponsor

Source ClinicalTrials.gov
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