Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT07038720
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of UA026 Tablets in Healthy Adult Subjects and Adult Subjects With Moderate to Severe Plaque Psoriasis
Sponsor:
Usynova Pharmaceuticals Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: