Clinical Trial

Evaluate the Safety and Pharmacokinetics/Pharmacodynamics and Food Effect of HS-20118

Recruiting Phase 1
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Record status
This record was last updated June 24, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
Summary
The study will be conducted in 2 parts (SAD and FE for Part 1 and MAD for Part2). Part 1 is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability, immunogenicity, and PK of HS-20118 and explore the food effect and fasting time on PK after a single oral dose in healthy participants. Part 2 is a multi-center, randomized, double-blind, placebo-controlled, MAD study to evaluate the safety, tolerability, immunogenicity, PK, and PD of HS-20118 after multiple oral doses in patients with moderate to severe plaque psoriasis.
Trial Details
NCT Number NCT07033234
Lead Sponsor Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions Psoriasis
Enrollment 142 participants
Start Date 2025-05-16
Primary Completion 2026-03 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2025-06-24