ASC50 for Plaque Psoriasis

Overseen By Vanessa Wang, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ascletis Pharma (China) Co., Limited

Must not be taking: Immunosuppressants

Disqualifiers: Pregnancy, Chronic medical conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

94 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tablet, ASC50, to determine its safety and effectiveness in treating plaque psoriasis, a skin condition that causes red, scaly patches. The researchers aim to understand how the body processes this treatment and whether eating affects its performance. Participants will receive either ASC50 tablets in varying doses or a placebo (a pill with no active drug) for comparison. Individuals with mild to moderate plaque psoriasis who can easily provide blood samples might be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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

The trial requires that you stop taking systemic immunosuppressive medications like methotrexate and cyclosporine at least 4 weeks before starting the study drug. If you're on these medications, you'll need to stop them before participating.

Is there any evidence suggesting that ASC50 tablets are likely to be safe for humans?

Research has shown that ASC50 is being tested for safety in treating plaque psoriasis. Early animal studies have shown promising results, indicating that ASC50 remains in the body longer and clears more slowly, which can sometimes aid in consistent treatment effects.

As this is a phase I trial, the primary focus is on the drug's safety for humans. Researchers closely monitor for any side effects or reactions during these early stages. Detailed data on human reactions to different doses of ASC50 is not yet available. The trial aims to assess tolerance and monitor any adverse events. Since it is in phase I, researchers are still collecting basic safety information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for psoriasis?

ASC50 is unique because it offers a new approach to treating plaque psoriasis. Most current treatments for this condition, like topical corticosteroids and biologics, focus on reducing inflammation or suppressing the immune system. However, ASC50 targets specific pathways involved in the development of psoriasis, potentially offering a more precise treatment. Researchers are excited about ASC50 because it might work faster and more effectively than existing options, with the added convenience of being taken as a tablet. This could lead to improved outcomes and greater ease for patients managing their condition.

What evidence suggests that ASC50 tablets might be an effective treatment for plaque psoriasis?

Research has shown that ASC50 may help treat plaque psoriasis. In animal studies, ASC50 proved very effective against psoriasis. This drug blocks IL-17, a protein involved in inflammation, which plays a key role in psoriasis. Although human studies provide limited information, early results suggest ASC50 could be a strong treatment option. The ongoing trial includes various treatment arms to evaluate different dosages of ASC50, its safety, and how well the body processes the drug. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy adults and those with mild to moderate plaque psoriasis. Participants must meet specific health criteria not detailed here, and cannot have conditions that would exclude them from safely participating as determined by the study guidelines.

Inclusion Criteria

Willing and able to give informed consent prior to any study specific procedures being performed

I can have blood drawn without difficulty.

I am between 18 and 65 years old.

Exclusion Criteria

Have any other conditions, which, in the opinion of the investigator or sponsor, would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study

I haven't taken any immune-suppressing drugs in the last 4 weeks.

History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the subject's safety during the clinical study or expose the subject to undue risk as judged by the Investigator

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 administration of ASC50 or placebo

1 day

1 visit (in-person)

Multiple Ascending Dose (MAD)

Participants receive ASC50 or placebo daily for 28 days

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ASC50 Tablets

Trial Overview The study tests ASC50 tablets against a placebo in a controlled environment. It's designed to see how safe the drug is, how the body reacts to it (pharmacokinetics), its effects on the body (pharmacodynamics), and if food changes anything.

How Is the Trial Designed?

Group I: SAD Cohort 6 Experimental Treatment 1 Intervention

Participants will receive a single ASC50 (Dose 6) administration or matching placebo

Group II: SAD Cohort 5 Experimental Treatment 1 Intervention

Participants will receive a single ASC50 (Dose 5) administration or matching placebo

Group III: SAD Cohort 4 Experimental Treatment 1 Intervention

Participants will receive a single ASC50 (Dose 4) administration or matching placebo

Group IV: SAD Cohort 3 Experimental Treatment 1 Intervention

Participants will receive a single ASC50 (Dose 3) administration or matching placebo

Group V: SAD Cohort 2 Experimental Treatment 1 Intervention

Participants will receive a single ASC50 (Dose 2) administration or matching placebo

Group VI: SAD Cohort 1 Experimental Treatment 1 Intervention

Participants will receive a single ASC50 (Dose 1) administration or matching placebo

Group VII: MAD Cohort 3 Experimental Treatment 1 Intervention

Participants will receive ASC50 (Dose 3) or matching placebo for 28 days, QD

Group VIII: MAD Cohort 2 Experimental Treatment 1 Intervention

Participants will receive ASC50 (Dose 2) or matching placebo for 28 days, QD

Group IX: MAD Cohort 1 Experimental Treatment 1 Intervention

Participants will receive ASC50 (Dose 1) or matching placebo for 28 days, QD

Who Is Running the Clinical Trial?

Ascletis Pharma (China) Co., Limited

Lead Sponsor

Trials

3

Recruited

180+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07024602

NCT07024602 | A Study to Evaluate the Safety, Tolerability ... This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics ...

2. dermatologytimes.com dermatologytimes.com/view/ascletis-receives-fda-clearance-to-advance-asc50-a-novel-oral-il-17-inhibitor-into-phase-1-psoriasis-trial

Ascletis Receives FDA Clearance to Advance ASC50, a ... The drug, ASC50, will be assessed in patients with mild to moderate plaque psoriasis, with the trial evaluating its safety, tolerability, and ...

3. withpower.com withpower.com/trial/phase-1-psoriasis-vulgaris-plaque-psoriasis-5-2025-f1408

ASC50 for Plaque Psoriasis Trial Overview The study tests ASC50 tablets against a placebo in a controlled environment. It's designed to see how safe the drug is, how the body reacts to it ...

4. prnewswire.com prnewswire.com/news-releases/ascletis-announces-first-participants-dosed-in-us-phase-i-clinical-study-of-asc50-a-potential-best-in-class-oral-small-molecule-il-17-inhibitor-for-the-treatment-of-psoriasis-302484058.html

Ascletis Announces First Participants Dosed in U.S. Phase ... The Phase I trial evaluates the safety, tolerability and preliminary efficacy of ASC50 for the treatment of psoriasis.

5. prnewswire.com prnewswire.com/news-releases/ascletis-announces-us-fda-clearance-of-ind-application-for-its-oral-small-molecule-il-17-inhibitor-asc50-for-the-treatment-of-psoriasis-302462995.html

Ascletis Announces U.S. FDA Clearance of IND Application ... Furthermore, ASC50 demonstrated strong efficacy in a psoriasis animal model. These preclinical data support ASC50 as a potential best-in-class ...

6. trialx.com trialx.com/clinical-trials/listings/324992/a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-pharmacodynamics-and-efficacy-of-asc50-tables-in-healthy-participants-and-participants-with-plaque-psoriasis/

A Study to Evaluate the Safety, Tolerability ... Clinical trial for Plaque Psoriasis , A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ASC50 ...

7. biospace.com biospace.com/press-releases/ascletis-announces-first-participants-dosed-in-u-s-phase-i-clinical-study-of-asc50-a-potential-best-in-class-oral-small-molecule-il-17-inhibitor-for-the-treatment-of-psoriasis

Ascletis Announces First Participants Dosed in U.S. Phase ... The Phase I trial evaluates the safety, tolerability and preliminary efficacy of ASC50 for the treatment of psoriasis. - Preclinical data ...