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

Launched by JIANGSU HANSOH PHARMACEUTICAL CO., LTD. · Jun 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called HS-20118 to see if it is safe and how it behaves in the body, especially for people with moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches. The study has two parts: the first part involves healthy volunteers who will take a single dose to check safety and how food affects the medicine, while the second part involves people with psoriasis who will take multiple doses to understand both safety and how well the medicine works over time.

If you are healthy and between 18 and 45 years old, you might be eligible for the first part. For the second part, participants need to be between 18 and 65 years old and have had plaque psoriasis for at least six months. During the study, participants will be closely monitored with medical exams and tests to ensure safety. Some people won’t qualify, such as those with certain immune diseases, recent infections, or other types of psoriasis. This study is currently recruiting volunteers who want to help researchers learn more about this potential new treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• For the SAD study:
• • 1. Healthy adults aged 18-45 years (inclusive) at the time of signing the informed consent form;
• • 2. Male participants weighing ≥ 50 kg and female participants weighing ≥ 45 kg, both ≤ 110 kg; body mass index (weight/square of height (kg/m2)) within the range of 18-28 kg/m2 (inclusive);
• • 3. Normal results or abnormal results but without clinical significance in comprehensive examinations, including general physical examination, vital signs, laboratory tests, 12-lead ECG, abdominal color Doppler ultrasound, and chest X-ray from the frontal and lateral position ;
• For the MAD study:
• • 1. Male or female participants aged 18-65 years (inclusive) at the time of signing the informed consent form;
• • 2. Male participants weighing ≥ 50 kg and female participants weighing ≥ 45 kg, both ≤ 110 kg;
• • 3. Chronic plaque psoriasis for at least 6 months with or without psoriatic arthritis;
• Exclusion Criteria:
• For the SAD study:
• • 1. Participants with immune-related diseases and medical history at screening;
• • 2. Participants with a history of drug or other allergies who are considered by the investigator to be at high risk for participating in this study, or who may be allergic to the investigational medicinal product or any component of the investigational medicinal product as judged by the investigator;
• • 3. History of drug abuse within the past 5 years or use of illicit drugs within 3 months before the study; or positive for urine drug screening;
• For the MAD study:
• • 1. Guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, drug-induced psoriasis, or other diseases that affect the treatment results;
• • 2. Current use of prohibited drugs or prior use of prohibited drugs within the specific time periods;
• • 3. Known history of recurrent or chronic infections, or prior history of chronic or recurrent infections, including but not limited to: chronic renal infection, chronic chest infection (e.g., bronchiectasis), symptomatic urinary tract infection, and open, draining, or infected skin wounds; history of serious infections (e.g., sepsis, pneumonia, and pyelonephritis), or hospitalization or treatment with intravenous antibiotics for infections within 2 months before screening;