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RECRUITING
NCT06846710
PHASE1

Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118

Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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 .

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2025-05-02

Completion Date

2027-02-28

Last Updated

2025-08-07

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

HS-20118

Single and multiple ascending doses of HS-20118 orally

OTHER

HS-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