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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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;
Primary outcome measure(s)
Incidence, sever ity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation — Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD) adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
Number of participants with abnormalities of physical examination — Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD) Physical examination includes skin, mucous membranes, lymph nodes, head, neck, chest, abdomen, and spine/limbs, etc.
Number of participants with abnormalities of vital signs — Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD) Vital sign measured include body temperature, blood pressure, pulse, and respiratory rate.
Number of participants with clinical laboratory abnormalities — Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD) Clinical laboratory tests include blood biochemistry test, hematology test, urinalysis, coagulation function test, etc.
Number of participants with abnormalities of electrocardiogram (ECG) parameters — Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD) ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.
Trial sites (1)
Facility
City
Region
Status
Affiliated Hangzhou First People's Hospital
Hangzhou
Zhejiang
Recruiting
More Jiangsu Hansoh Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.