Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06846710
Registration number
NCT06846710
Ethics application status
Date submitted
12/02/2025
Date registered
26/02/2025
Date last updated
7/08/2025
Titles & IDs
Public title
Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
HS-20118-101
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Psoriasis
0
0
Query!
Condition category
Condition code
Skin
0
0
0
0
Query!
Dermatological conditions
Query!
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - HS-20118
Other interventions - HS-20118 placebo
Experimental: 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
Treatment: Drugs: HS-20118
Single and multiple ascending doses of HS-20118 orally
Other interventions: HS-20118 placebo
Single and multiple ascending doses of HS-20118-matched placebo orally
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
Query!
Assessment method [1]
0
0
adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
Query!
Timepoint [1]
0
0
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Query!
Primary outcome [2]
0
0
Number of participants with abnormalities of physical examination
Query!
Assessment method [2]
0
0
Physical examination includes skin, mucous membranes, lymph nodes, head, neck, chest, abdomen, and spine/limbs, etc.
Query!
Timepoint [2]
0
0
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Query!
Primary outcome [3]
0
0
Number of participants with abnormalities of vital signs
Query!
Assessment method [3]
0
0
Vital sign measured include body temperature, blood pressure, pulse, and respiratory rate.
Query!
Timepoint [3]
0
0
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Query!
Primary outcome [4]
0
0
Number of participants with clinical laboratory abnormalities
Query!
Assessment method [4]
0
0
Clinical laboratory tests include blood biochemistry test, hematology test, urinalysis, coagulation function test, etc.
Query!
Timepoint [4]
0
0
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Query!
Primary outcome [5]
0
0
Number of participants with abnormalities of electrocardiogram (ECG) parameters
Query!
Assessment method [5]
0
0
ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.
Query!
Timepoint [5]
0
0
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Query!
Secondary outcome [1]
0
0
Cmax
Query!
Assessment method [1]
0
0
Maximum plasma concentration
Query!
Timepoint [1]
0
0
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Query!
Secondary outcome [2]
0
0
Tmax
Query!
Assessment method [2]
0
0
Time to reach Cmax
Query!
Timepoint [2]
0
0
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Query!
Secondary outcome [3]
0
0
AUC
Query!
Assessment method [3]
0
0
Area under the plasma concentration-time curve
Query!
Timepoint [3]
0
0
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Query!
Secondary outcome [4]
0
0
t½
Query!
Assessment method [4]
0
0
Terminal half-life
Query!
Timepoint [4]
0
0
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Query!
Secondary outcome [5]
0
0
CL/F
Query!
Assessment method [5]
0
0
Apparent clearance
Query!
Timepoint [5]
0
0
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Query!
Secondary outcome [6]
0
0
Vd/F
Query!
Assessment method [6]
0
0
Apparent volume of distribution
Query!
Timepoint [6]
0
0
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Query!
Secondary outcome [7]
0
0
Rac
Query!
Assessment method [7]
0
0
Accumulation ratio
Query!
Timepoint [7]
0
0
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Query!
Secondary outcome [8]
0
0
Incidence of Anti-drug antibody (ADA)
Query!
Assessment method [8]
0
0
Anti-drug antibody (ADA)
Query!
Timepoint [8]
0
0
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Query!
Secondary outcome [9]
0
0
Proportions of psoriasis area and severity index (PASI) 75
Query!
Assessment method [9]
0
0
The PASI assessment will assess erythema, thickening (plaque evaluation, induration), and scaling (desquamation) on the head, trunk, upper limbs, and lower limbs, respectively
Query!
Timepoint [9]
0
0
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Query!
Secondary outcome [10]
0
0
Proportions of psoriasis area and severity index (PASI) 90
Query!
Assessment method [10]
0
0
The PASI assessment will assess erythema, thickening (plaque evaluation, induration), and scaling (desquamation) on the head, trunk, upper limbs, and lower limbs, respectively
Query!
Timepoint [10]
0
0
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Query!
Secondary outcome [11]
0
0
Proportions of psoriasis area and severity index (PASI) 100
Query!
Assessment method [11]
0
0
The PASI assessment will assess erythema, thickening (plaque evaluation, induration), and scaling (desquamation) on the head, trunk, upper limbs, and lower limbs, respectively
Query!
Timepoint [11]
0
0
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Query!
Secondary outcome [12]
0
0
Proportions of Investigator's Global Assessment (IGA) 0/1
Query!
Assessment method [12]
0
0
The investigator scores each of infiltration/hypertrophy (I), erythema (E), and scaling (S) as a whole
Query!
Timepoint [12]
0
0
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Query!
Secondary outcome [13]
0
0
Proportions of Investigator's Global Assessment (IGA) 0
Query!
Assessment method [13]
0
0
The investigator scores each of infiltration/hypertrophy (I), erythema (E), and scaling (S) as a whole
Query!
Timepoint [13]
0
0
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Query!
Secondary outcome [14]
0
0
Change from baseline in psoriasis area and severity index (PASI) total score
Query!
Assessment method [14]
0
0
The PASI assessment will assess erythema, thickening (plaque evaluation, induration), and scaling (desquamation) on the head, trunk, upper limbs, and lower limbs, respectively
Query!
Timepoint [14]
0
0
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Query!
Secondary outcome [15]
0
0
Change from baseline in body surface area (BSA)
Query!
Assessment method [15]
0
0
The total BSA affected by plaque psoriasis is estimated based on the percent area affected, including head, trunk, upper extremities, and lower extremities
Query!
Timepoint [15]
0
0
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Query!
Secondary outcome [16]
0
0
Change from baseline in dermatology life quality index (DLQI)
Query!
Assessment method [16]
0
0
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
Query!
Timepoint [16]
0
0
Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Query!
Eligibility
Key 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;
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
65
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key 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;
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Other
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
2/05/2025
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
28/02/2027
Query!
Actual
Query!
Sample size
Target
132
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
New Zealand
Query!
State/province [3]
0
0
Auckland
Query!
Country [4]
0
0
New Zealand
Query!
State/province [4]
0
0
Christchurch
Query!
Country [5]
0
0
New Zealand
Query!
State/province [5]
0
0
Dunedin
Query!
Country [6]
0
0
New Zealand
Query!
State/province [6]
0
0
Pukekohe
Query!
Country [7]
0
0
New Zealand
Query!
State/province [7]
0
0
Upper Hutt
Query!
Country [8]
0
0
New Zealand
Query!
State/province [8]
0
0
Wellington Region
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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 .
Query!
Trial website
https://clinicaltrials.gov/study/NCT06846710
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06846710
Download to PDF