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

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

This trial will test whether oral HS-20118 is safe and how the body processes it in healthy adults and in people with moderate to severe plaque psoriasis, including whether food changes absorption.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 142 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07033234 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults (18–65) with chronic plaque psoriasis of at least six months’ duration who meet the trial's weight and health criteria and can attend study visits.

Not a fit: People with only mild psoriasis, non‑plaque forms of psoriasis, significant uncontrolled medical conditions, pregnancy, or those enrolled as healthy volunteers in Part 1 should not expect therapeutic benefit from participation.

Why it matters

Potential benefit: If successful, HS-20118 could become a new oral treatment option for plaque psoriasis with a favorable safety and dosing profile.

How similar studies have performed: Other oral systemic agents and many biologic therapies have shown benefit in psoriasis, but HS-20118 is an investigational molecule in early human testing with limited prior clinical data.

Eligibility criteria

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 this trial is running

Hangzhou, Zhejiang

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

Study contacts

• Study coordinator: Liming Wu Director of Dermatology

Conditions Psoriasis; psoriasis