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

NCT07033234 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2025-06-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

HS-20118

HS-20118

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-16
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07033234 on ClinicalTrials.gov