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

Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study ID
NCT07033234
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • HS-20118 — DRUG
    HS-20118

Study Details

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.

Key Dates

First listed
Jun 24, 2025
Start date
May 16, 2025
Status verified
Jun 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
142 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: HS-20118
    Single and multiple ascending doses of HS-20118 orally
  • Placebo Comparator: Placebo
    Single and multiple ascending doses of HS-20118-matched placebo orally

Primary Outcome Measure

Incidence, sever ity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation [ Time Frame: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD) ]

Central Contacts

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