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

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: Recruiting
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: ASC50 tablets or matching placebo

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Vanessa Wang, MD; Phone Number: +86 18986192094; Email: global.clinical@ascletis.com

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33144
      • Recruiting
      • Ascletis Clinical Site

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Adverse Events	Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)	Up to Day 7
Adverse Events	Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)	Up to Day 43

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC	Evaluate the Area under the plasma concentration versus time curve of ASC50	Up to Day 7
AUC	Evaluate the Area under the plasma concentration versus time curve of ASC50	Up to Day 34
Cmax	Evaluate the Peak Plasma Concentration of ASC50	Up to Day 7
Cmax	Evaluate the Peak Plasma Concentration of ASC50	Up to Day 34
T1/2	Evaluate the Terminal-Phase Half-Life of ASC50	Up to Day 7
T1/2	Evaluate the Terminal-Phase Half-Life of ASC50	Up to Day 34
Tmax	Evaluate the time to reach the maximum concentration of ASC50	Up to Day 7
Tmax	Evaluate the time to reach the maximum concentration of ASC50	Up to Day 34
IL-17A	Changes in IL-17A after ASC50 administration	Up to Day 7
IL-17A	Changes in IL-17A after ASC50 administration	Up to Day 29
Beta Defensin-2	Changes in Beta Defensin-2 after ASC50 administration	Up to Day 29
IL-19	Changes in IL-19 after ASC50 administration	Up to Day 29
Psoriasis Area and Severity Index (PASI)	Changes in Psoriasis Area and Severity Index (PASI) after ASC50 treatment.	Up to Day 43
Target Lesion Severity Score (TLSS)	Changes in Target Lesion Severity Score (TLSS)after ASC50 treatment.	Up to Day 43

Collaborators and Investigators

• Sponsor: Ascletis Pharma (China) Co., Limited

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 2, 2025
• First Submitted That Met QC Criteria: June 9, 2025
• First Posted (Actual): June 17, 2025

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: June 9, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Plaque Psoriasis; ASC50
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis
• Other Study ID 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