Actively Recruiting
Evaluate the Safety and Pharmacokinetics/Pharmacodynamics and Food Effect of HS-20118
Led by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Updated on 2025-06-24
142
Participants Needed
1
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluate the Safety and Pharmacokinetics/Pharmacodynamics and Food Effect of HS-20118
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For the SAD study: Healthy adults aged 18-45 years at consent
- Male participants weighing 50 kg or more and female participants weighing 45 kg or more, both 110 kg or less
- Body mass index between 18 and 28 kg/m2 inclusive
- Normal or clinically insignificant abnormal results in physical exams, vital signs, lab tests, ECG, abdominal ultrasound, and chest X-ray
- For the MAD study: Male or female participants aged 18-65 years at consent
- Male participants weighing 50 kg or more and female participants weighing 45 kg or more, both 110 kg or less
- Chronic plaque psoriasis for at least 6 months with or without psoriatic arthritis
You will not qualify if you...
- For the SAD study: Immune-related diseases or medical history at screening
- History of drug or other allergies posing high risk or allergy to the study drug or its components
- History of drug abuse within 5 years or illicit drug use within 3 months; positive urine drug screening
- For the MAD study: Guttate, pustular, erythrodermic, drug-induced psoriasis, or other diseases affecting treatment
- Current or recent use of prohibited drugs within specific time periods
- History of recurrent or chronic infections including chronic renal or chest infections, symptomatic urinary tract infection, or infected skin wounds
- History of serious infections or hospitalization for infections within 2 months before screening
AI-Screening
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Trial Site Locations
Total: 1 location
1
Affiliated Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
L
Liming Wu Director of Dermatology
CONTACT
Y
Ying Wang Director of GCP Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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