PsoriasisPhase 1NCT07033234
Evaluate the Safety and Pharmacokinetics/Pharmacodynamics and Food Effect of HS-20118
A Phase 1 study testing HS-20118 in people with Psoriasis, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- HS-20118
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2025to Mar 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Affiliated Hangzhou First People's Hospital
Hangzhou, Zhejiang
Liming Wu Director of Dermatology, +8613750837205, 18957118053@163.com
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of HS-20118, and the Food Effect (FE) on the Pharmacokinetics in Adult Participants
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.
Read the detailed description
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 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. It is planned to select a dose group in SAD to conduct a food effect study (to explore the possible effects of fasting time after taking the medicine and low-fat meals on HS-20118 PK).
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.
- Conditions
- Psoriasis
- Being tested
- HS-20118
- Keywords
- psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-20118Drug
HS-20118
| Study group | Role | What they receive |
|---|---|---|
| HS-20118 | Experimental | Single and multiple ascending doses of HS-20118 orally Receives: Drug: HS-20118 |
| Placebo | Placebo comparator | Single and multiple ascending doses of HS-20118-matched placebo orally Receives: Drug: HS-20118 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Secondary outcomes (16)
Cmax
Maximum plasma concentration
Measured: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Tmax
Time to reach Cmax
Measured: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
AUC
Area under the plasma concentration-time curve
Measured: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
t½
Terminal half-life
Measured: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
CL/F
Apparent clearance
Measured: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Vd/F
Apparent volume of distribution
Measured: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Rac
Accumulation ratio
Measured: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Incidence of Anti-drug antibody (ADA)
Anti-drug antibody (ADA)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start16 May 2025
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033234
- Sponsor's protocol ID
- HS-20118-102
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of HS-20118, and the Food Effect (FE) on the Pharmacokinetics in Adult Participants
- ClinicalTrials.gov ID
- NCT07033234
- Acronym / sponsor ID
- HS-20118-102
- Conditions
- Psoriasis
- Keywords
- psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 May 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 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. It is planned to select a dose group in SAD to conduct a food effect study (to explore the possible effects of fasting time after taking the medicine and low-fat meals on HS-20118 PK).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-20118 | Experimental | Drug: HS-20118Single and multiple ascending doses of HS-20118 orally |
| Placebo | Placebo comparator | Drug: HS-20118Single and multiple ascending doses of HS-20118-matched placebo orally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 ;
- 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;
Key exclusion criteria (8 listed)
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-20118HS-20118 | Drug | HS-20118, Placebo |
Primary outcome
Incidence, sever ity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
Time frame: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
Number of participants with abnormalities of physical examination
Time frame: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Physical examination includes skin, mucous membranes, lymph nodes, head, neck, chest, abdomen, and spine/limbs, etc.
Number of participants with abnormalities of vital signs
Time frame: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Vital sign measured include body temperature, blood pressure, pulse, and respiratory rate.
Number of participants with clinical laboratory abnormalities
Time frame: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Clinical laboratory tests include blood biochemistry test, hematology test, urinalysis, coagulation function test, etc.
Number of participants with abnormalities of electrocardiogram (ECG) parameters
Time frame: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.
16 secondary outcomes
Cmax
Time frame: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Tmax
Time frame: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
AUC
Time frame: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
t½
Time frame: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
CL/F
Time frame: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Vd/F
Time frame: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Rac
Time frame: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Incidence of Anti-drug antibody (ADA)
Time frame: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Proportions of psoriasis area and severity index (PASI) 75
Time frame: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Proportions of psoriasis area and severity index (PASI) 90
Time frame: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Proportions of psoriasis area and severity index (PASI) 100
Time frame: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Proportions of Investigator's Global Assessment (IGA) 0/1
Time frame: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Proportions of Investigator's Global Assessment (IGA) 0
Time frame: 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
Time frame: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Change from baseline in body surface area (BSA)
Time frame: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Change from baseline in dermatology life quality index (DLQI)
Time frame: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-20118 in people with Psoriasis, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liming Wu Director of Dermatology (+86 13750837205, 18957118053@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, sever ity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation (time frame: Day 1 up to Day 36 (SAD), Day 1 up to Day 71 (MAD)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.