NCT07038720

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Usynova Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Plaque Psoriasis
• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	UA026	UA026 will be administered as tablet
DRUG	Placebo	Matching placebo will be administered as tablet

Timeline

• Start date: 2025-05-08
• Primary completion: 2026-03-01
• Completion: 2026-06-01
• First posted: 2025-06-26
• Last updated: 2025-11-17

Locations

1 site across 1 country: China