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NCT Number: NCT07024602

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ascletis Clinical Site

Miami, Florida, 33144, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

ASC50 tablets or matching placebo

Drug

Drug: ASC50 administered orally Drug: Placebo administered orally

Primary outcomes

  1. Adverse Events

    Time frame: Up to Day 7

    Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)

  2. Adverse Events

    Time frame: Up to Day 43

    Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)

Secondary outcomes

  1. AUC

    Time frame: Up to Day 7

    Evaluate the Area under the plasma concentration versus time curve of ASC50

  2. AUC

    Time frame: Up to Day 34

    Evaluate the Area under the plasma concentration versus time curve of ASC50

  3. Cmax

    Time frame: Up to Day 7

    Evaluate the Peak Plasma Concentration of ASC50

  4. Cmax

    Time frame: Up to Day 34

    Evaluate the Peak Plasma Concentration of ASC50

  5. T1/2

    Time frame: Up to Day 7

    Evaluate the Terminal-Phase Half-Life of ASC50

  6. T1/2

    Time frame: Up to Day 34

    Evaluate the Terminal-Phase Half-Life of ASC50

  7. Tmax

    Time frame: Up to Day 7

    Evaluate the time to reach the maximum concentration of ASC50

  8. Tmax

    Time frame: Up to Day 34

    Evaluate the time to reach the maximum concentration of ASC50

  9. IL-17A

    Time frame: Up to Day 7

    Changes in IL-17A after ASC50 administration

  10. IL-17A

    Time frame: Up to Day 29

    Changes in IL-17A after ASC50 administration

  11. Beta Defensin-2

    Time frame: Up to Day 29

    Changes in Beta Defensin-2 after ASC50 administration

  12. IL-19

    Time frame: Up to Day 29

    Changes in IL-19 after ASC50 administration

  13. Psoriasis Area and Severity Index (PASI)

    Time frame: Up to Day 43

    Changes in Psoriasis Area and Severity Index (PASI) after ASC50 treatment.

  14. Target Lesion Severity Score (TLSS)

    Time frame: Up to Day 43

    Changes in Target Lesion Severity Score (TLSS)after ASC50 treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Vanessa Wang, MD

CONTACT

[email protected]

+86 18986192094

Sponsors and collaborators

Lead sponsor

Ascletis Pharma (China) Co., Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2025
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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