HS-20118 for Psoriasis

Recruiting at 8 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Disqualifiers: Immune diseases, Drug allergies, Drug abuse, others

Compensation: Varies

Number of Visits: Unknown

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HS-20118 to evaluate its safety and mechanism in the body. It targets individuals with moderate to severe plaque psoriasis, a condition causing red, scaly patches. The trial consists of two parts: one for healthy participants to test a single dose and another for psoriasis patients to test multiple doses. Individuals with plaque psoriasis for at least six months and related joint issues might be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in humans.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that HS-20118 is likely to be safe for humans?

Research shows that HS-20118 remains in the early testing stages, so its safety is not yet fully known. This Phase 1 trial marks the first time the treatment is tested for safety in humans.

In similar studies, researchers closely monitor treatments at this stage for any side effects or reactions. They exercise great care and vigilance for any problems. Participants might not have much information about long-term effects, but the treatment is considered safe enough to try in small doses with careful observation.

Since HS-20118 is still under investigation, those interested in joining the trial should understand that more information is needed to fully assess its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

HS-20118 is unique because it offers a new way to tackle psoriasis through its novel mechanism of action. Unlike current treatments like topical corticosteroids or biologics that focus on suppressing the immune system, HS-20118 works by targeting specific pathways involved in inflammation at the cellular level. This targeted approach may lead to fewer side effects and more precise treatment outcomes. Researchers are excited because it could mean a more effective and safer option for psoriasis patients, potentially improving their quality of life significantly.

What evidence suggests that HS-20118 might be an effective treatment for psoriasis?

Research into HS-20118 remains in the early stages, so limited information exists on its effectiveness for treating psoriasis. In this trial, participants will receive either HS-20118 or a placebo. HS-20118 targets specific parts of the immune system believed to be involved in psoriasis. This targeting may help reduce the inflammation and skin cell buildup that cause the red, scaly patches typical of psoriasis. Initial studies focus on understanding how the drug works in the body and assessing its safety. Although it is too early to determine the effectiveness of HS-20118, the trial aims to evaluate its potential in managing symptoms of moderate to severe plaque psoriasis. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy adults with chronic plaque psoriasis, weighing between 45-110 kg and a BMI of 18-28. They must have had psoriasis for at least six months and show normal or non-significant abnormal results in physical exams, vital signs, lab tests, ECGs, ultrasounds, and chest X-rays.

Inclusion Criteria

I am a healthy adult, aged 18-45, with a normal weight and no significant health issues.

I am 18-65 years old, weigh within the required range, and have had plaque psoriasis for at least 6 months.

Exclusion Criteria

For the SAD study: Participants with immune-related diseases and medical history at screening; Participants with a history of drug or other allergies considered high risk 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 urine drug screening

For the MAD study: Guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, drug-induced psoriasis, or other diseases affecting treatment results; Current use of illicit drugs or prior use within specific time periods; Known history of recurrent or chronic infections, including but not limited to chronic renal infection, chronic chest infection, symptomatic urinary tract infection, and open, draining, or infected skin wounds; history of serious infections, hospitalization, or treatment with intravenous antibiotics for infections within 2 months before screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive a single oral dose of HS-20118 to evaluate safety, tolerability, immunogenicity, and pharmacokinetics

5 weeks

Multiple visits for PK, ADA, PD blood sampling and safety examinations

Multiple Ascending Dose (MAD)

Participants receive multiple oral doses of HS-20118 to evaluate safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics

10 weeks

Multiple visits for PK, ADA, PD blood sampling and safety examinations

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HS-20118

Trial Overview The study evaluates HS-20118's safety and effects on the body after one dose (Part 1) in healthy people and multiple doses (Part 2) in those with moderate to severe plaque psoriasis. It's randomized and placebo-controlled; some participants will receive HS-20118 while others get a placebo.

How Is the Trial Designed?

Group I: HS-20118 Experimental Treatment 1 Intervention

Single and multiple ascending doses of HS-20118 orally

Group II: placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Lead Sponsor

Trials

109

Recruited

22,400+

Zhong Huijuan

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Chief Executive Officer since 1995

Background in chemistry and education

Dr. Lyu Aifeng

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Chief Medical Officer since 2023

MD, PhD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07033234

Study Details | NCT07033234 | Evaluate the Safety and ... 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 ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06846710/evaluate-the-safety-and-pharmacokinetics-pharmacodynamics-of-hs-20118

Evaluate the Safety and Pharmacokinetics ... Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118 ; Condition. Skin Wounds. Scalp Disorders. Warts ; Treatment. HS-20118 ...

3. synapse.patsnap.com synapse.patsnap.com/drug/4ae13dc07c8e4e79ba5308989c2a4740

HS-20118 - Drug Targets, Indications, Patents A Phase I Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of ...

4. go.drugbank.com go.drugbank.com/conditions/DBCOND0013339

Psoriasis (DBCOND0013339) Associated Data ; NCT06125808. Efficacy and Safety Study of HRO350 in Patients with Mild-to-moderate Psoriasis (the 'HeROPA' Study). No drug interventions ...

5. withpower.com withpower.com/clinical-trials/for-psoriasis-near-los-angeles-ca?page=2

61 Psoriasis Trials near Los Angeles, CA 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 ...

6. trialx.com trialx.com/clinical-trials/listings/325081/evaluate-the-safety-and-pharmacokineticspharmacodynamics-and-food-effect-of-hs-20118/

Evaluate the Safety and Pharmacokinetics ... Clinical trial for Psoriasis , Evaluate the Safety and Pharmacokinetics/Pharmacodynamics and Food Effect of HS-20118.

7. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/579076

Evaluate the Safety and Pharmacokinetics ... A single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability, immunogenicity, and PK of HS-20118 after a ...

8. ctv.veeva.com ctv.veeva.com/study/evaluate-the-safety-and-pharmacokinetics-pharmacodynamics-of-hs20118

Evaluate the Safety and Pharmacokinetics ... A single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability, immunogenicity, and PK of HS-20118 after a ...