NCT07033234

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

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of HS-20118, and the Food Effect (FE) on the Pharmacokinetics in Adult Participants

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

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 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. It is planned to select a dose group in SAD to conduct a food effect study (to explore the possible effects of fasting time after taking the medicine and low-fat meals on HS-20118 PK). 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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	HS-20118	HS-20118

Timeline

• Start date: 2025-05-16
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-06-24
• Last updated: 2025-06-24

Locations

1 site across 1 country: China