HS-20118 safety, how the body handles it, and food effects in healthy people and those with plaque psoriasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial has two parts: Part 1 is a single-ascending-dose, randomized, double-blind, placebo-controlled study in healthy volunteers that includes a food-effect evaluation, and Part 2 is a multi-center, randomized, double-blind, placebo-controlled multiple-ascending-dose study in patients with moderate to severe plaque psoriasis. Key measures include safety, tolerability, immunogenicity (ADA), pharmacokinetics (PK) and pharmacodynamics (PD) with scheduled blood sampling and clinical safety exams. Part 1 plans five dose cohorts of 12 healthy participants each (9 active:3 placebo) with a selected cohort tested for food and fasting effects, and Part 2 plans six patient cohorts of 12 each (9 active:3 placebo) receiving multiple doses. Overall enrollment is planned at about 60 healthy volunteers in Part 1 and 72 patients in Part 2, with standard monitoring for adverse events and laboratory changes.

Why it matters

Who can join: the full rules

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;

Where it's running

• Affiliated Hangzhou First People's Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Liming Wu Director of Dermatology
• Email: 18957118053@163.com
• Phone: +86 13750837205

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• HB0017 Injection safety and PK in low-weight adults at different injection sites

  This early-phase study tests a single subcutaneous HB0017 injection in healthy, low-weight adults and compares how the body processes the drug when injected at different sites.

  Recruiting Phase 1 Huabo Biopharm Co., Ltd. · Hangzhou, Zhejiang · NCT07920861

• MK-8644: first-in-human test in healthy people and people with psoriasis

  This early-phase study tests MK-8644 versus placebo in healthy volunteers and people with psoriasis to see if it is safe and tolerable.

  Recruiting Phase 1 Merck Sharp & Dohme LLC · Melbourne, Victoria · NCT07850310

• Is XJH05 Ointment Effective for Plaque Psoriasis?

  This study tests whether the XJH05 ointment can help people with plaque psoriasis compare to a calcipotriol ointment.

  Recruiting Xijing Hospital · Xi'an, Shaanxi · NCT07780929

• Guselkumab after Ustekinumab in adults with moderate-to-severe psoriasis in routine care

  This study looks at how well guselkumab works for people with moderate-to-severe psoriasis after switching from ustekinumab in everyday clinical practice.

  Recruiting Janssen-Cilag Kft. · Budapest · NCT07746583

• TQH3906 capsules vs warmer options in adults with moderate to severe plaque psoriasis

  This Phase 3 trial tests whether once-daily TQH3906 capsules can help adults with moderate to severe plaque psoriasis better than a placebo or the active drug deucravacitinib.

  Recruiting at 13 sites Phase 3 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Beijing, Beijing Municipality and 44 other locations · NCT07724366

• SHR-1139 injectable treatment for adults with plaque psoriasis

  This study tests whether an SHR-1139 injection works and is safe for adults with plaque psoriasis.

  Recruiting Phase 2 Guangdong Hengrui Pharmaceutical Co., Ltd · Guangzhou, Guangzhou · NCT07719530

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.