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Clinical Trial NCT06846710 for Psoriasis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118 Phase 1 132 Randomized Double-Blind Placebo-Controlled Multi-Center
Clinical Trial NCT06846710 is designed to study Treatment for Psoriasis. It is a Phase 1 interventional study that is recruiting, having started on 2 May 2025, with plans to enroll 132 participants. Led by Jiangsu Hansoh Pharmaceutical Co., Ltd., it is expected to complete by 28 February 2027. The latest data from ClinicalTrials.gov was last updated on 7 August 2025.
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...
Show MoreDetailed 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 rec...
Show MoreOfficial 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
Conditions
PsoriasisOther Study IDs
- HS-20118-101
NCT ID Number
Start Date (Actual)
2025-05-02
Last Update Posted
2025-08-07
Completion Date (Estimated)
2027-02-28
Enrollment (Estimated)
132
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Keywords
Psoriasis
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Sequential
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalHS-20118 Single and multiple ascending doses of HS-20118 orally | HS-20118 Single and multiple ascending doses of HS-20118 orally |
Placebo Comparatorplacebo Single and multiple ascending doses of HS-20118-matched placebo orally | HS-20118 placebo Single and multiple ascending doses of HS-20118-matched placebo orally |
Primary Outcome Measures
Secondary 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) |
| 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) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
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;
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 illicit drugs or prior use of illicit 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;
No contact data.
9 Study Locations in 2 Countries
Auckland
Pacific Clinical Research Network (PCRN), Auckland, Takapuna, Auckland, 0622, New Zealand
Paul Hamilton, Contact, +64 22 585 0357, [email protected]
Recruiting
Christchurch
Pacific Clinical Research Network (PCRN), Christchurch, Christchurch, Christchurch, 8013, New Zealand
Benjamin Image, Contact, +64 03 337 1979, [email protected]
Not yet recruiting
Dunedin
Momentum Clinical Research, Dunedin, Dunedin, Dunedin, 9016, New Zealand
Sarah Hortop, Contact, +64 03 974 8170, [email protected]
Not yet recruiting
Pukekohe
Momentum Clinical Research, Pukekohe, Pukekohe, Pukekohe, 2120, New Zealand
Moushumi Das, Contact, +64 9 237 0121, [email protected]
Not yet recruiting
Upper Hutt
Pacific Clinical Research Network (PCRN), Wellington, Upper Hutt, Upper Hutt, 5018, New Zealand
Tim Humphrey, Contact, +64 21 653 212, [email protected]
Not yet recruiting
Wellington Region
Momentum Clinical Research, Wellington, Mount Cook, Wellington Region, 6021, New Zealand
Joanna Joseph, Contact, +64 4 801 0002, [email protected]
Not yet recruiting
California
Kinetic Clinical Research, Anaheim, California, 92806, United States
Marguerite Critelli, Contact, (714) 441-9178, [email protected]
Not yet recruiting
Florida
Clinitiative - Floridian Clinical Research, LLC, Miami Lakes, Florida, 33016, United States
William Eduardo Sanchez, Contact, (305) 330-9977, [email protected]
Not yet recruiting
NuLine Clinical Trial Center (Network), Pompano Beach, Florida, 33060, United States
Steven Glanz, Contact, (855)-501-1071, [email protected]
Not yet recruiting