Evaluate the Safety and Pharmacokinetics/Pharmacodynamics and Food Effect of HS-20118
Recruiting · NCT07033234 · Interventional (participants receive a specific treatment) · Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
HS-20118
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- For the SAD study:
- Healthy adults aged 18-45 years (inclusive) at the time of signing the informed consent form;
- 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);
- 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:
- Male or female participants aged 18-65 years (inclusive) at the time of signing the informed consent form;
- Male participants weighing ≥ 50 kg and female participants weighing ≥ 45 kg, both ≤ 110 kg;
- Chronic plaque psoriasis for at least 6 months with or without psoriatic arthritis;
Exclusion criteria
- For the SAD study:
- Participants with immune-related diseases and medical history at screening;
- 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;
- 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:
- Guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, drug-induced psoriasis, or other diseases that affect the treatment results;
- Current use of prohibited drugs or prior use of prohibited drugs within the specific time periods;
- 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;
Where it is running
1 location listed.
- Affiliated Hangzhou First People's Hospital - Hangzhou, Zhejiang, China