drugset / Trial / NCT07033234

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

NCT07033234 ↗

Phase 1 Recruiting 142 enrolled Jiangsu Hansoh Pharmaceutical Co., Ltd.
RandomizedSequentialQuadruple-blindTreatment

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.

Timeline

Start
2025-05-16
Primary completion
2026-03
Completion
2026-03

Drugs

EvaluationDrugModalityDoseRoute
Subject HS-20118 Unknown — Oral

Indications