Testing the safety and how HS-20118 is processed in the body

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

This trial tests oral HS-20118 to see if it is safe and how it is processed in the body when given as a single dose to healthy adults and as multiple doses to adults with moderate to severe plaque psoriasis.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. (industry)
• Locations: 9 sites (Anaheim, California and 8 other locations)
• Trial ID: NCT06846710 on ClinicalTrials.gov

What this trial studies

The trial has two parts: a single-ascending-dose (SAD) part in healthy adults and a multiple-ascending-dose (MAD) part in patients with moderate to severe plaque psoriasis. Part 1 is a single-center, randomized, double-blind, placebo-controlled SAD with five single-dose cohorts (12 participants per cohort) to measure safety, tolerability, immunogenicity, and pharmacokinetics. Part 2 is a multi-center, randomized, double-blind, placebo-controlled MAD with up to six multiple-dose cohorts (12 participants per cohort) in psoriasis patients to measure safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics. Participants will undergo scheduled blood sampling for PK, PD, and anti-drug antibodies and routine safety examinations during dosing and follow-up.

Who should consider this trial

Good fit: Healthy adults 18–45 without significant medical issues are eligible for the single-dose part, and adults 18–65 with chronic moderate to severe plaque psoriasis are eligible for the multiple-dose part, within the trial's specified weight and BMI ranges.

Not a fit: People with mild or non-plaque forms of psoriasis or those who fall outside the trial's age, weight, or BMI eligibility are unlikely to receive benefit from participating.

Why it matters

Potential benefit: If HS-20118 proves safe and shows favorable activity, it could become a new oral treatment option for people with moderate to severe plaque psoriasis.

How similar studies have performed: Other oral small-molecule therapies have benefited people with plaque psoriasis, but HS-20118 is a novel compound and its safety and activity in humans have not yet been established.

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 illicit drugs or prior use of illicit 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

Anaheim, California and 8 other locations

• Kinetic Clinical Research — Anaheim, California, United States (NOT_YET_RECRUITING)
• Clinitiative - Floridian Clinical Research, LLC — Miami Lakes, Florida, United States (NOT_YET_RECRUITING)
• NuLine Clinical Trial Center (Network) — Pompano Beach, Florida, United States (NOT_YET_RECRUITING)
• Pacific Clinical Research Network (PCRN), Auckland — Takapuna, Auckland, New Zealand (RECRUITING)
• Pacific Clinical Research Network (PCRN), Christchurch — Christchurch, Christchurch, New Zealand (NOT_YET_RECRUITING)
• Momentum Clinical Research, Dunedin — Dunedin, Dunedin, New Zealand (NOT_YET_RECRUITING)
• Momentum Clinical Research, Pukekohe — Pukekohe, Pukekohe, New Zealand (NOT_YET_RECRUITING)
• Pacific Clinical Research Network (PCRN), Wellington — Upper Hutt, Upper Hutt, New Zealand (NOT_YET_RECRUITING)
• Momentum Clinical Research, Wellington — Mount Cook, Wellington Region, New Zealand (NOT_YET_RECRUITING)

Conditions: Psoriasis