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

Phase 1

Recruiting

• Conditions: Plaque Psoriasis
• Interventions: Drug: ASC50 tablets or matching placebo

• Registration Number: NCT07024602
• Lead Sponsor: Ascletis Pharma (China) Co., Limited

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06
• Study First Submitted: 2025-06-02
• Study First Submitted QC: 2025-06-09
• Last Update Submitted: 2025-06-09
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SAD Cohort 2	ASC50 tablets or matching placebo	Participants will receive a single ASC50 (Dose 2) administration or matching placebo
MAD Cohort 2	ASC50 tablets or matching placebo	Participants will receive ASC50 (Dose 2) or matching placebo for 28 days, QD
SAD Cohort 1	ASC50 tablets or matching placebo	Participants will receive a single ASC50 (Dose 1) administration or matching placebo
SAD Cohort 3	ASC50 tablets or matching placebo	Participants will receive a single ASC50 (Dose 3) administration or matching placebo
SAD Cohort 4	ASC50 tablets or matching placebo	Participants will receive a single ASC50 (Dose 4) administration or matching placebo
SAD Cohort 5	ASC50 tablets or matching placebo	Participants will receive a single ASC50 (Dose 5) administration or matching placebo
SAD Cohort 6	ASC50 tablets or matching placebo	Participants will receive a single ASC50 (Dose 6) administration or matching placebo
MAD Cohort 1	ASC50 tablets or matching placebo	Participants will receive ASC50 (Dose 1) or matching placebo for 28 days, QD
MAD Cohort 3	ASC50 tablets or matching placebo	Participants will receive ASC50 (Dose 3) or matching placebo for 28 days, QD

Primary Outcome Measures

Name	Time	Method
Adverse Events	Up to Day 43	Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ascletis Clinical Site; 🇺🇸 Miami, Florida, United States