Evaluate the Safety and Pharmacokinetics/Pharmacodynamics and Food Effect of HS-20118

NCT07033234 | Recruiting Phase 1

• 1 other identifier: HS-20118-102
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be conducted in 2 parts (SAD and FE 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 and explore the food effect and fasting time on PK 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.

Conditions

Psoriasis

Keywords

psoriasis

Outcome Measures

Primary Outcomes (5)

• Incidence, sever ity 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 Outcomes (16)

• Cmax

  Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

• Tmax

  Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

• AUC

  Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

• t½

  Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

• CL/F

  Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)

Study Arms (2)

HS-20118

EXPERIMENTAL

Single and multiple ascending doses of HS-20118 orally

Drug: HS-20118

Placebo

PLACEBO COMPARATOR

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

Drug: HS-20118

Interventions

HS-20118 DRUG

HS-20118

HS-20118; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For the SAD study:
• Healthy adults aged 18-45 years (inclusive) at the time of signing the informed consent form;
• 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);
• 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:
• Male or female participants aged 18-65 years (inclusive) at the time of signing the informed consent form;
• Male participants weighing ≥ 50 kg and female participants weighing ≥ 45 kg, both ≤ 110 kg;
• Chronic plaque psoriasis for at least 6 months with or without psoriatic arthritis;

You may not qualify if:

• For the SAD study:
• Participants with immune-related diseases and medical history at screening;
• 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;
• 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:
• Guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, drug-induced psoriasis, or other diseases that affect the treatment results;
• Current use of prohibited drugs or prior use of prohibited drugs within the specific time periods;
• 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;

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Affiliated Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Liming Wu Director of Dermatology

CONTACT

+86 13750837205; 18957118053@163.com

Ying Wang Director of GCP Office

CONTACT

+86 18367124548; nancywangying@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 24, 2025
• Study Start: May 16, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

CN (1)