Ireland
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Recruiting Phase 1

Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118

NCT06846710 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2025-05-02
Last updated
2025-08-07

Condition(s) studied

Psoriasis

Investigational drug(s) / intervention(s)

HS-20118 →HS-20118 placebo

HS-20118: Single and multiple ascending doses of HS-20118 orally

HS-20118 placebo: Single and multiple ascending doses of HS-20118-matched placebo orally

Study summary

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 .

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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;

Primary outcome measure(s)

  • Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation — Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
    adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
  • Number of participants with abnormalities of physical examination — Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
    Physical examination includes skin, mucous membranes, lymph nodes, head, neck, chest, abdomen, and spine/limbs, etc.
  • Number of participants with abnormalities of vital signs — Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
    Vital sign measured include body temperature, blood pressure, pulse, and respiratory rate.
  • Number of participants with clinical laboratory abnormalities — Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
    Clinical laboratory tests include blood biochemistry test, hematology test, urinalysis, coagulation function test, etc.
  • Number of participants with abnormalities of electrocardiogram (ECG) parameters — Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
    ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.

Trial sites (9)

FacilityCityRegionStatus
Kinetic Clinical Research Anaheim California Not Yet Recruiting
Clinitiative - Floridian Clinical Research, LLC Miami Lakes Florida Not Yet Recruiting
NuLine Clinical Trial Center (Network) Pompano Beach Florida Not Yet Recruiting
Pacific Clinical Research Network (PCRN), Auckland Takapuna Auckland Recruiting
Pacific Clinical Research Network (PCRN), Christchurch Christchurch Christchurch Not Yet Recruiting
Momentum Clinical Research, Dunedin Dunedin Dunedin Not Yet Recruiting
Momentum Clinical Research, Pukekohe Pukekohe Pukekohe Not Yet Recruiting
Pacific Clinical Research Network (PCRN), Wellington Upper Hutt Upper Hutt Not Yet Recruiting
Momentum Clinical Research, Wellington Mount Cook Wellington Region Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06846710 on ClinicalTrials.gov ↗ ← All trials in the USA