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

NCT07024602 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ASC50-101
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque Psoriasis

Keywords

ASC50; Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• AUC

  Up to Day 7

• AUC

  Up to Day 34

• Cmax

  Up to Day 7

• Cmax

  Up to Day 34

• T1/2

  Up to Day 7

Study Arms (9)

SAD Cohort 1

EXPERIMENTAL

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

Drug: ASC50 tablets or matching placebo

SAD Cohort 2

EXPERIMENTAL

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

Drug: ASC50 tablets or matching placebo

SAD Cohort 3

EXPERIMENTAL

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

Drug: ASC50 tablets or matching placebo

SAD Cohort 4

EXPERIMENTAL

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

Drug: ASC50 tablets or matching placebo

SAD Cohort 5

EXPERIMENTAL

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

Drug: ASC50 tablets or matching placebo

SAD Cohort 6

EXPERIMENTAL

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

Drug: ASC50 tablets or matching placebo

MAD Cohort 1

EXPERIMENTAL

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

Drug: ASC50 tablets or matching placebo

MAD Cohort 2

EXPERIMENTAL

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

Drug: ASC50 tablets or matching placebo

MAD Cohort 3

EXPERIMENTAL

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

Drug: ASC50 tablets or matching placebo

Interventions

ASC50 tablets or matching placebo DRUG

Drug: ASC50 administered orally Drug: Placebo administered orally

MAD Cohort 1; MAD Cohort 2; MAD Cohort 3; SAD Cohort 1; SAD Cohort 2; SAD Cohort 3; SAD Cohort 4; SAD Cohort 5; SAD Cohort 6

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Female participants who are pregnant, breastfeeding or plan to be pregnant during the study period and 3 months after last dose.
• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Ascletis Clinical Site

Miami, Florida, 33144, United States

RECRUITING

Central Study Contacts

Vanessa Wang, MD

CONTACT

+86 18986192094; global.clinical@ascletis.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 17, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)