A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ASC50 Tables in Healthy Participants and Participants With Plaque Psoriasis

June 9, 2025 updated by: Ascletis Pharma (China) Co., Limited

A Phase I, Randomized, Double-blind, Placebo Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of ASC50 Tablets in Healthy Adult Participants and Adult Participants With Mild to Moderate Plaque Psoriasis

This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, food effect of ASC50 tablets in healthy adult participants and adult participants with mild to moderate plaque psoriasis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33144
        • Recruiting
        • Ascletis clinical site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male and female participants between 18 to 65 years of age inclusive, at the time of screening.
  2. Willing and able to give informed consent prior to any study specific procedures being performed.
  3. Have venous access sufficient to allow for blood sampling

Exclusion Criteria:

  1. Female participants who are pregnant, breastfeeding or plan to be pregnant during the study period and 3 months after last dose.
  2. 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.
  3. Have received systemic immunosuppressive therapy (MTX, apremilast, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) within 4 weeks of first administration of study drug.
  4. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SAD Cohort 1
Participants will receive a single ASC50 (Dose 1) administration or matching placebo
Drug: ASC50 tablets or matching placebo
Drug: ASC50 administered orally Drug: Placebo administered orally
Experimental: SAD Cohort 2
Participants will receive a single ASC50 (Dose 2) administration or matching placebo
Drug: ASC50 tablets or matching placebo
Drug: ASC50 administered orally Drug: Placebo administered orally
Experimental: SAD Cohort 3
Participants will receive a single ASC50 (Dose 3) administration or matching placebo
Drug: ASC50 tablets or matching placebo
Drug: ASC50 administered orally Drug: Placebo administered orally
Experimental: SAD Cohort 4
Participants will receive a single ASC50 (Dose 4) administration or matching placebo
Drug: ASC50 tablets or matching placebo
Drug: ASC50 administered orally Drug: Placebo administered orally
Experimental: SAD Cohort 5
Participants will receive a single ASC50 (Dose 5) administration or matching placebo
Drug: ASC50 tablets or matching placebo
Drug: ASC50 administered orally Drug: Placebo administered orally
Experimental: SAD Cohort 6
Participants will receive a single ASC50 (Dose 6) administration or matching placebo
Drug: ASC50 tablets or matching placebo
Drug: ASC50 administered orally Drug: Placebo administered orally
Experimental: MAD Cohort 1
Participants will receive ASC50 (Dose 1) or matching placebo for 28 days, QD
Drug: ASC50 tablets or matching placebo
Drug: ASC50 administered orally Drug: Placebo administered orally
Experimental: MAD Cohort 2
Participants will receive ASC50 (Dose 2) or matching placebo for 28 days, QD
Drug: ASC50 tablets or matching placebo
Drug: ASC50 administered orally Drug: Placebo administered orally
Experimental: MAD Cohort 3
Participants will receive ASC50 (Dose 3) or matching placebo for 28 days, QD
Drug: ASC50 tablets or matching placebo
Drug: ASC50 administered orally Drug: Placebo administered orally

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Up to Day 7
Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)
Up to Day 7
Adverse Events
Time Frame: Up to Day 43
Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)
Up to Day 43

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AUC
Time Frame: Up to Day 7
Evaluate the Area under the plasma concentration versus time curve of ASC50
Up to Day 7
AUC
Time Frame: Up to Day 34
Evaluate the Area under the plasma concentration versus time curve of ASC50
Up to Day 34
Cmax
Time Frame: Up to Day 7
Evaluate the Peak Plasma Concentration of ASC50
Up to Day 7
Cmax
Time Frame: Up to Day 34
Evaluate the Peak Plasma Concentration of ASC50
Up to Day 34
T1/2
Time Frame: Up to Day 7
Evaluate the Terminal-Phase Half-Life of ASC50
Up to Day 7
T1/2
Time Frame: Up to Day 34
Evaluate the Terminal-Phase Half-Life of ASC50
Up to Day 34
Tmax
Time Frame: Up to Day 7
Evaluate the time to reach the maximum concentration of ASC50
Up to Day 7
Tmax
Time Frame: Up to Day 34
Evaluate the time to reach the maximum concentration of ASC50
Up to Day 34
IL-17A
Time Frame: Up to Day 7
Changes in IL-17A after ASC50 administration
Up to Day 7
IL-17A
Time Frame: Up to Day 29
Changes in IL-17A after ASC50 administration
Up to Day 29
Beta Defensin-2
Time Frame: Up to Day 29
Changes in Beta Defensin-2 after ASC50 administration
Up to Day 29
IL-19
Time Frame: Up to Day 29
Changes in IL-19 after ASC50 administration
Up to Day 29
Psoriasis Area and Severity Index (PASI)
Time Frame: Up to Day 43
Changes in Psoriasis Area and Severity Index (PASI) after ASC50 treatment.
Up to Day 43
Target Lesion Severity Score (TLSS)
Time Frame: Up to Day 43
Changes in Target Lesion Severity Score (TLSS)after ASC50 treatment.
Up to Day 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ascletis Pharma (China) Co., Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ASC50-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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