Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118

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

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 .

Study Overview

• Status: Recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Drug: HS-20118; Other: HS-20118 placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Christchurch, New Zealand, 8013
    • Not yet recruiting
    • Pacific Clinical Research Network (PCRN), Christchurch
    • Contact: Benjamin Image; Phone Number: +64 03 337 1979; Email: benimage@pcrn.co.nz
  • Dunedin, New Zealand, 9016
    • Not yet recruiting
    • Momentum Clinical Research, Dunedin
    • Contact: Sarah Hortop; Phone Number: +64 03 974 8170; Email: Sarah.Hortop@momentumclinicalresearch.co.nz
  • Pukekohe, New Zealand, 2120
    • Not yet recruiting
    • Momentum Clinical Research, Pukekohe
    • Contact: Moushumi Das; Phone Number: +64 9 237 0121; Email: Moushumi.Das@momentumclinicalresearch.co.nz
  • Upper Hutt, New Zealand, 5018
    • Not yet recruiting
    • Pacific Clinical Research Network (PCRN), Wellington
    • Contact: Tim Humphrey; Phone Number: +64 21 653 212; Email: tim.humphrey@LCTwellington.co.nz
  • Auckland
    • Takapuna, Auckland, New Zealand, 0622
      • Recruiting
      • Pacific Clinical Research Network (PCRN), Auckland
      • Contact: Paul Hamilton; Phone Number: +64 22 585 0357; Email: paulhamilton@pcrn.co.nz
  • Wellington
    • Mount Cook, Wellington, New Zealand, 6021
      • Not yet recruiting
      • Momentum Clinical Research, Wellington
      • Contact: Joanna Joseph; Phone Number: +64 4 801 0002; Email: joanna.joseph@momentumclinicalresearch.co.nz
• United States
  • California
    • Anaheim, California, United States, 92806
      • Not yet recruiting
      • Kinetic Clinical Research
      • Contact: Marguerite Critelli; Phone Number: (714) 441-9178; Email: marguerite.critelli@kineticclinical.com
  • Florida
    • Miami Lakes, Florida, United States, 33016
      • Not yet recruiting
      • Clinitiative - Floridian Clinical Research, LLC
      • Contact: William Eduardo Sanchez; Phone Number: (305) 330-9977; Email: wsanchezmd@floridiancr.com
    • Pompano Beach, Florida, United States, 33060
      • Not yet recruiting
      • NuLine Clinical Trial Center (Network)
      • Contact: Steven Glanz; Phone Number: (855)-501-1071; Email: sglanz@nulineclinicaltrial.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HS-20118; Single and multiple ascending doses of HS-20118 orally	Drug: HS-20118; Single and multiple ascending doses of HS-20118 orally
Placebo Comparator: placebo; Single and multiple ascending doses of HS-20118-matched placebo orally	Other: HS-20118 placebo; Single and multiple ascending doses of HS-20118-matched placebo orally

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum plasma concentration	Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Tmax	Time to reach Cmax	Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
AUC	Area under the plasma concentration-time curve	Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
t½	Terminal half-life	Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
CL/F	Apparent clearance	Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Vd/F	Apparent volume of distribution	Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Rac	Accumulation ratio	Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Incidence of Anti-drug antibody (ADA)	Anti-drug antibody (ADA)	Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Proportions of psoriasis area and severity index (PASI) 75	The PASI assessment will assess erythema, thickening (plaque evaluation, induration), and scaling (desquamation) on the head, trunk, upper limbs, and lower limbs, respectively	Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Proportions of psoriasis area and severity index (PASI) 90	The PASI assessment will assess erythema, thickening (plaque evaluation, induration), and scaling (desquamation) on the head, trunk, upper limbs, and lower limbs, respectively	Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Proportions of psoriasis area and severity index (PASI) 100	The PASI assessment will assess erythema, thickening (plaque evaluation, induration), and scaling (desquamation) on the head, trunk, upper limbs, and lower limbs, respectively	Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Proportions of Investigator's Global Assessment (IGA) 0/1	The investigator scores each of infiltration/hypertrophy (I), erythema (E), and scaling (S) as a whole	Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Proportions of Investigator's Global Assessment (IGA) 0	The investigator scores each of infiltration/hypertrophy (I), erythema (E), and scaling (S) as a whole	Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Change from baseline in psoriasis area and severity index (PASI) total score	The PASI assessment will assess erythema, thickening (plaque evaluation, induration), and scaling (desquamation) on the head, trunk, upper limbs, and lower limbs, respectively	Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Change from baseline in body surface area (BSA)	The total BSA affected by plaque psoriasis is estimated based on the percent area affected, including head, trunk, upper extremities, and lower extremities	Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Change from baseline in dermatology life quality index (DLQI)	The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne, and viral warts	Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Collaborators and Investigators

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: February 20, 2025
• First Posted (Actual): February 26, 2025

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis
• Other Study ID Numbers: HS-20118-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No