NCT07033234RecruitingPhase 1
Evaluate the Safety and Pharmacokinetics/Pharmacodynamics and Food Effect of HS-20118
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of HS-20118, and the Food Effect (FE) on the Pharmacokinetics in Adult Participants
Source: ClinicalTrials.gov · Last updated 24 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 142 (estimated)
- First submitted
- 3 Jun 2025
- Start date
- 16 May 2025
- Primary completion date
- Mar 2026
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Diseases
- Psoriasis
- NCT number
- NCT07033234
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 142
- From 16 May 2025 to the primary completion date, Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
- 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;
Other illness
- 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;
- Guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, drug-induced psoriasis, or other diseases that affect the treatment results;
Other
- For the SAD study:
Who the study is looking for
- 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;
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Affiliated Hangzhou First People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.