NCT06846710 · Jiangsu Hansoh Pharmaceutical Co., Ltd.
Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118
What this study is about
The study will be conducted in 2 parts (SAD for Part 1 and MAD for Part2). Part 1 is a single-center, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment, SAD study to evaluate the safety, tolerability, immunogenicity, and PK of HS-20118 after a single taken by mouth dose in healthy participants.
View original scientific description
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 .
Interventions
DRUG
HS-20118
Single and multiple ascending doses of HS-20118 orally
OTHER
HS-20118 placebo
Single and multiple ascending doses of HS-20118-matched placebo orally
Primary outcome measures
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 illicit drugs or prior use of illicit 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
- Anaheim, California
- Miami Lakes, Florida
- Pompano Beach, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 7, 2025 · Source of record for eligibility and locations