Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118
Start Date
5/2/2025
Completion Date
2/28/2027
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 .
Detailed Description
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 1 will consist of 5 cohorts, i.e., X1 mg, X2 mg, X3 mg, X4 mg, and X5 mg dose cohorts (each cohort will include 3 participants to receive placebo). There will be no restriction on the male-to-female ratio. Each cohort will include 12 participants (HS-20118:placebo = 9:3), with a total of 60 participants. Participants will undergo PK blood sampling, ADA blood sampling, PD blood sampling and safety examinations during the study. 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. Part 2 will tentatively consist of 6 cohorts ( HS-20118 vs placebo = 9:3), i.e., (1) A1 mg, (2) A2 mg, (3) A3 mg, (4) A4 mg, (5) A5 mg, (6) A6 mg. Each cohort will include 12 participants (HS-20118:placebo = 9:3), with a total of 72 participants. There will be no restriction on the male-to-female ratio. Participants will undergo PK blood sampling, ADA blood sampling, PD blood sampling and safety examinations during the study.
Eligibility Criteria
Age Range: 18 years to 65 years
Interventions
HS-20118
HS-20118 placebo
Conditions
Locations
Kinetic Clinical Research
Anaheim, California 92806
United States
Clinitiative - Floridian Clinical Research, LLC
Miami Lakes, Florida 33016
United States
NuLine Clinical Trial Center (Network)
Pompano Beach, Florida 33060
United States
Pacific Clinical Research Network (PCRN), Auckland
Takapuna, Auckland 0622
New Zealand
Pacific Clinical Research Network (PCRN), Christchurch
Christchurch, Christchurch 8013
New Zealand
Momentum Clinical Research, Dunedin
Dunedin, Dunedin 9016
New Zealand
Momentum Clinical Research, Pukekohe
Pukekohe, Pukekohe 2120
New Zealand
Pacific Clinical Research Network (PCRN), Wellington
Upper Hutt, Upper Hutt 5018
New Zealand
Momentum Clinical Research, Wellington
Mount Cook, Wellington Region 6021
New Zealand