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

Phase 1

Recruiting

• Conditions: Plaque Psoriasis; Healthy Volunteer
• Interventions: Drug: UA026; Drug: Placebo

• Registration Number: NCT07038720
• Lead Sponsor: Usynova Pharmaceuticals Ltd.

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.

Detailed Description

Interleukin (IL)-17A is a proinflammatory cytokine that when dysregulated can lead to inflammatory disorders. Inhibiting IL-17A has shown remarkable clinical efficacy in psoriasis.UA026 is a high potency small molecule IL-17A inhibitor. This first-in-human study assessed the safety, tolerability, pharmacokinetics (PKs), and biomarkers including circulating IL-17A target engagement profile of single or multiple oral doses of the UA026 in healthy subject and subjects with moderate to severe plaque psoriasis.

Study Timeline

• Study Start: 2025-05-08
• Status Verified: 2025-06
• Study First Submitted: 2025-06-08
• Study First Submitted QC: 2025-06-17
• Last Update Submitted: 2025-06-17
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Primary Completion: 2026-03-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
UA026	UA026	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
Placebo	Placebo	Part A: SAD in healthy subjects Part B: MAD in healthy subjects Part D: Multiple dose study in psoriasis patients

Primary Outcome Measures

Name	Time	Method
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	up to 56 days	Safety and tolerability outcome measures include, but are not limited to vital signs, physical examination, 12-lead ECGs, clinical laboratory tests, and adverse events.
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 Outcome Measures

Name	Time	Method
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
Apparent systemic clearance (CL/F) for Parts A, B, and C	up to 72 hours after the last dose
Apparent volume of distribution (Vz/F) for Parts A, B, and C	up to 72 hours after the last dose
MRT（Mean Residence Time）for Parts A, B, C and D	up to 72 hours after the last dose
Accumulation ratios (Rac) for Parts B and D	up to 72 hours after the last dose
degree of fluctuation（DF）for Parts B and D	up to 72 hours after the last dose
the change in serum IL-17A level from the baseline for Parts A, B and D	up to 72 hours after the last dose
the changes in serum beta-defensin 2(BD-2) from the baseline for Part D	up to 72 hours after the last dose
the changes in serum IL-19 level from the baseline for Part D	up to 72 hours after the last dose
The percentage change in psoriasis area and severity index (PASI) score from the baseline for Part D	up to 56 days
Number of Participants Achieving 50% Improvement from Baseline in PASI (PASI-50) Score for Part D	up to 56 days
Number of Participants Achieving 75% Improvement from Baseline in PASI (PASI-75) Score	up to 56 days
Number of Participants Achieving 90% Improvement from Baseline in PASI (PASI-90) Score	up to 56 days
Number of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) for Part D	up to 56 days
The change in sPGA score from the baseline for Part D	up to 56 days
The change in body surface area(BSA) from the baseline for Part D	up to 56 days

Trial Locations

Locations (1)

Hangzhou First People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China