Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118

Last updated: August 4, 2025
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Rash

Skin Wounds

Warts

Treatment

HS-20118 placebo

HS-20118

Clinical Study ID

NCT06846710
HS-20118-101
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

Inclusion Criteria:

For the SAD study:

  1. Healthy adults aged 18-45 years (inclusive) at the time of signing the informedconsent 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 18-28kg/m2 (inclusive);

  3. Normal results or abnormal results but without clinical significance incomprehensive examinations, including general physical examination, vital signs,laboratory tests, 12-lead ECG, abdominal color Doppler ultrasound, and chest X-rayfrom the frontal and lateral position ;

For the MAD study:

  1. Male or female participants aged 18-65 years (inclusive) at the time of signing theinformed 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

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 theinvestigator to be at high risk for participating in this study, or who may beallergic to the investigational medicinal product or any component of theinvestigational medicinal product as judged by the investigator;

  3. History of drug abuse within the past 5 years or use of illicit drugs within 3months before the study; or positive for urine drug screening;

For the MAD study:

  1. Guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, drug-inducedpsoriasis, or other diseases that affect the treatment results;

  2. Current use of illicit drugs or prior use of illicit drugs within the specific timeperiods;

  3. Known history of recurrent or chronic infections, or prior history of chronic orrecurrent infections, including but not limited to: chronic renal infection, chronicchest infection (e.g., bronchiectasis), symptomatic urinary tract infection, andopen, draining, or infected skin wounds; history of serious infections (e.g.,sepsis, pneumonia, and pyelonephritis), or hospitalization or treatment withintravenous antibiotics for infections within 2 months before screening;

Study Design

Total Participants: 132
Treatment Group(s): 2
Primary Treatment: HS-20118 placebo
Phase: 1
Study Start date:
May 02, 2025
Estimated Completion Date:
February 28, 2027

Study Description

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 1 will consist of 5 cohorts, i.e., X1 mg, X2 mg, X3 mg, X4 mg, and X5 mg dose cohorts (each cohort will include 3 participants to receive placebo). There will be no restriction on the male-to-female ratio. Each cohort will include 12 participants (HS-20118:placebo = 9:3), with a total of 60 participants. Participants will undergo PK blood sampling, ADA blood sampling, PD blood sampling and safety examinations during the study.

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.

Part 2 will tentatively consist of 6 cohorts ( HS-20118 vs placebo = 9:3), i.e., (1) A1 mg, (2) A2 mg, (3) A3 mg, (4) A4 mg, (5) A5 mg, (6) A6 mg. Each cohort will include 12 participants (HS-20118:placebo = 9:3), with a total of 72 participants. There will be no restriction on the male-to-female ratio. Participants will undergo PK blood sampling, ADA blood sampling, PD blood sampling and safety examinations during the study.

Connect with a study center

  • Pacific Clinical Research Network (PCRN), Auckland

    Takapuna, Auckland 0622
    New Zealand

    Active - Recruiting

  • Momentum Clinical Research, Wellington

    Mount Cook, Wellington 6021
    New Zealand

    Site Not Available

  • Pacific Clinical Research Network (PCRN), Christchurch

    Christchurch, 8013
    New Zealand

    Site Not Available

  • Momentum Clinical Research, Dunedin

    Dunedin, 9016
    New Zealand

    Site Not Available

  • Momentum Clinical Research, Pukekohe

    Pukekohe, 2120
    New Zealand

    Site Not Available

  • Pacific Clinical Research Network (PCRN), Wellington

    Upper Hutt, 5018
    New Zealand

    Site Not Available

  • Kinetic Clinical Research

    Anaheim, California 92806
    United States

    Site Not Available

  • Clinitiative - Floridian Clinical Research, LLC

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • NuLine Clinical Trial Center (Network)

    Pompano Beach, Florida 33060
    United States

    Site Not Available

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