Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118

Launched by JIANGSU HANSOH PHARMACEUTICAL CO., LTD. · Feb 20, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new medication called HS-20118 to see how safe it is and how it affects the body in people with moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches. The trial has two parts: the first part involves healthy adults who will take a single dose of the medication, while the second part will include patients with psoriasis who will take multiple doses. The main goals are to check for any side effects, how the body processes the medication, and how well it works.

To join the trial, participants must meet certain criteria. For the first part, healthy adults aged 18 to 45 are eligible, while for the second part, individuals aged 18 to 65 with a history of chronic plaque psoriasis for at least six months can participate. Participants can expect to undergo various health checks and monitoring throughout the study, including assessments of vital signs and laboratory tests. It's important to note that some individuals with certain medical conditions or a history of specific infections may not be able to participate. This trial is not yet recruiting participants, but it aims to help improve treatment options for psoriasis in the future.

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 illicit drugs or prior use of illicit 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;