RECRUITING

Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 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 .

Official Title

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

Quick Facts

Study Start:2025-05-02

Study Completion:2027-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06846710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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 ; 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;	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; 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;

Inclusion Criteria

Exclusion Criteria

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 ;
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;

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;
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;

Contacts and Locations

Study Locations (Sites)

Kinetic Clinical Research

Anaheim, California, 92806

United States

Clinitiative - Floridian Clinical Research, LLC

Miami Lakes, Florida, 33016

United States

NuLine Clinical Trial Center (Network)

Pompano Beach, Florida, 33060

United States

Collaborators and Investigators

Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-02

Study Completion Date2027-02-28

Study Record Updates

Study Start Date2025-05-02

Study Completion Date2027-02-28

Terms related to this study

Keywords Provided by Researchers

Psoriasis

Additional Relevant MeSH Terms

Psoriasis