NCT06846710CompletedPhase 1
Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of HS-20118 in Adult Participants
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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 .
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 12 Feb 2025
- Start date
- 2 May 2025
- Primary completion date
- 14 Jul 2026
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Diseases
- Psoriasis
- NCT number
- NCT06846710
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 60
- From 2 May 2025 to the primary completion date, 14 Jul 2026
- 9 sites in 2 countries
- 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 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;
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 (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pacific Clinical Research Network (PCRN) - Christchurch Coordinator of this site? Confirm its status | Christchurch | New Zealand | Unknown status |
| Momentum Clinical Research, Dunedin Coordinator of this site? Confirm its status | Dunedin | New Zealand | Unknown status |
| Momentum Clinical Research Wellington Coordinator of this site? Confirm its status | Mount Cook | New Zealand | Unknown status |
| Momentum Clinical Research - Pukekohe Coordinator of this site? Confirm its status | Pukekohe | New Zealand | Unknown status |
| Pacific Clinical Research Network (PCRN) - Auckland Coordinator of this site? Confirm its status | Takapuna | New Zealand | Unknown status |
| Pacific Clinical Research Network (PCRN), Wellington Coordinator of this site? Confirm its status | Upper Hutt | New Zealand | Unknown status |
| Kinetic Clinical Research Coordinator of this site? Confirm its status | Anaheim | United States | Unknown status |
| Clinitiative - Floridian Clinical Research, LLC Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| NuLine Clinical Trial Center (Network) Coordinator of this site? Confirm its status | Pompano Beach | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.