Recruiting
Phase 1

ASC50

Sponsor:

Ascletis Pharma (China) Co., Limited

Code:

NCT07024602

Conditions

Plaque Psoriasis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

ASC50 tablets or matching placebo

Study Details

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

Study ID

NCT07024602

Start date

Jun, 2025

Status verified date

Jun, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Enrollment

94 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SAD Cohort 1

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

experimental: SAD Cohort 2

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

experimental: SAD Cohort 3

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

experimental: SAD Cohort 4

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

experimental: SAD Cohort 5

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

experimental: SAD Cohort 6

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

experimental: MAD Cohort 1

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

experimental: MAD Cohort 2

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

experimental: MAD Cohort 3

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

Interventions

ASC50 tablets or matching placebo

Drug: ASC50 administered orally Drug: Placebo administered orally

Primary outcome measure

  • Adverse Events [ Time Frame: Up to Day 7 ]
  • Adverse Events [ Time Frame: Up to Day 43 ]

Central Contacts and Locations

Central contacts

Locations

Ascletis Clinical Site

Recruiting

Miami, Florida, United States, 33144

More Information

Sponsor

Ascletis Pharma (China) Co., Limited

Last update posted

Jun 17, 2025

Last verified

Jun, 2025

Keywords

  • ASC50
  • Plaque Psoriasis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ascletis Pharma (China) Co., Limited on 2025-06-17.