Actively Recruiting
Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118
Led by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Updated on 2025-08-07
132
Participants Needed
9
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 .
CONDITIONS
Official Title
Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18-45 years for SAD, or adults aged 18-65 years for MAD
- Male participants weighing at least 50 kg and female participants weighing at least 45 kg, both weighing no more than 110 kg
- Body mass index between 18 and 28 kg/m2 for SAD
- Normal or clinically insignificant abnormal results in physical exams, vital signs, lab tests, ECG, ultrasound, and chest X-ray for SAD
- Chronic plaque psoriasis for at least 6 months, with or without psoriatic arthritis, for MAD
You will not qualify if you...
- Immune-related diseases or medical history for SAD
- History of drug or other allergies that pose high risk or allergy to the study drug or its components for SAD
- History of drug abuse within 5 years or illicit drug use within 3 months before the study, or positive urine drug screening for SAD
- Guttate, pustular, erythrodermic, drug-induced psoriasis, or other diseases affecting treatment for MAD
- Current or recent illicit drug use for MAD
- History of recurrent or chronic infections or serious infections requiring hospitalization or intravenous antibiotics within 2 months before screening for MAD
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Kinetic Clinical Research
Anaheim, California, United States, 92806
Not Yet Recruiting
2
Clinitiative - Floridian Clinical Research, LLC
Miami Lakes, Florida, United States, 33016
Not Yet Recruiting
3
NuLine Clinical Trial Center (Network)
Pompano Beach, Florida, United States, 33060
Not Yet Recruiting
4
Pacific Clinical Research Network (PCRN), Auckland
Takapuna, Auckland, New Zealand, 0622
Actively Recruiting
5
Pacific Clinical Research Network (PCRN), Christchurch
Christchurch, Christchurch, New Zealand, 8013
Not Yet Recruiting
6
Momentum Clinical Research, Dunedin
Dunedin, Dunedin, New Zealand, 9016
Not Yet Recruiting
7
Momentum Clinical Research, Pukekohe
Pukekohe, Pukekohe, New Zealand, 2120
Not Yet Recruiting
8
Pacific Clinical Research Network (PCRN), Wellington
Upper Hutt, Upper Hutt, New Zealand, 5018
Not Yet Recruiting
9
Momentum Clinical Research, Wellington
Mount Cook, Wellington Region, New Zealand, 6021
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here