ASC50 tablets for safety and dosing in healthy adults and people with plaque psoriasis

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

This trial will test ASC50 tablets to see if they are safe and how they act in the body in healthy adults and adults with mild to moderate plaque psoriasis.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 94 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Ascletis Pharma Inc (Industry-sponsored)
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT07024602 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, randomized, double-blind, placebo-controlled single- and multiple-ascending-dose trial testing ASC50 tablets in healthy volunteers and adults with mild to moderate plaque psoriasis. The study measures safety, tolerability, pharmacokinetics, pharmacodynamics, and the effect of food on dosing. Participants will be assigned to dose cohorts with blood sampling for PK/PD and safety monitoring, and some cohorts will receive placebo for comparison. Results will inform safe dose ranges and early biological activity for future studies.

Who should consider this trial

Good fit: Adults aged 18 to 65 with mild to moderate plaque psoriasis who can give informed consent and tolerate frequent blood sampling are the intended participants.

Not a fit: People who are pregnant or breastfeeding, have severe psoriasis, recent use of systemic immunosuppressants, or other significant medical conditions are unlikely to be eligible or to benefit from this Phase 1 dosing study.

Why it matters

Potential benefit: If successful, ASC50 could provide information needed to develop a new oral treatment option with defined dosing and safety for people with plaque psoriasis.

How similar studies have performed: Phase 1 trials of novel oral agents for psoriasis have sometimes shown acceptable safety and early activity, but ASC50 is being tested in humans in this early-stage trial so its effects are not yet established.

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.

Where this trial is running

Miami, Florida

• Ascletis Clinical Site — Miami, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Vanessa Wang, MD

Conditions Plaque Psoriasis; ASC50