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

Launched by ASCLETIS PHARMA (CHINA) CO., LIMITED · Jun 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called ASC50, which is being tested to see if it is safe and well-tolerated in adults, including those with mild to moderate plaque psoriasis—a common skin condition that causes red, scaly patches. The study is in its early phase (Phase 1) and involves both healthy adults and adults with plaque psoriasis. Researchers want to understand how the medicine is processed in the body, how it works, and whether food affects it.

Adults between 18 and 65 years old who are generally healthy or have mild to moderate plaque psoriasis may be eligible to join. Participants must be able to give informed consent and have good vein access for blood tests. Pregnant or breastfeeding women, or those planning pregnancy soon, are not eligible. The study includes careful monitoring through blood samples and may involve taking different doses of the medicine to see how the body responds. Participants won’t know if they’re receiving ASC50 or a placebo (a pill with no active medicine), as the study is “double-blind” to ensure unbiased results. This trial is currently recruiting volunteers interested in helping to learn more about this potential new treatment.

Gender

ALL

Eligibility criteria

• 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.