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Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
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
HS-20118
Single and multiple ascending doses of HS-20118 orally
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