RecruitingPhase 1NCT06846710

Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of HS-20118 in Adult Participants


Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Enrollment

132 participants

Start Date

May 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study will be conducted in 2 parts (SAD 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 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 .


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called HS-20118 and HS-20118 placebo for people with psoriasis. The study is currently recruiting participants at 9 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHS-20118

Single and multiple ascending doses of HS-20118 orally

OTHERHS-20118 placebo

Single and multiple ascending doses of HS-20118-matched placebo orally


Locations(9)

Kinetic Clinical Research

Anaheim, California, United States

Clinitiative - Floridian Clinical Research, LLC

Miami Lakes, Florida, United States

NuLine Clinical Trial Center (Network)

Pompano Beach, Florida, United States

Pacific Clinical Research Network (PCRN), Auckland

Takapuna, Auckland, New Zealand

Pacific Clinical Research Network (PCRN), Christchurch

Christchurch, Christchurch, New Zealand

Momentum Clinical Research, Dunedin

Dunedin, Dunedin, New Zealand

Momentum Clinical Research, Pukekohe

Pukekohe, Pukekohe, New Zealand

Pacific Clinical Research Network (PCRN), Wellington

Upper Hutt, Upper Hutt, New Zealand

Momentum Clinical Research, Wellington

Mount Cook, Wellington Region, New Zealand

View Full Details on ClinicalTrials.gov

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NCT06846710


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