Clinical trial NCT07024602: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ASC50 Tables in Healthy Participants and Participants With Plaque Psoriasis
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Plaque Psoriasis
Keywords: ASC50
Plaque Psoriasis
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2025-06-17
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Adverse Events
timeFrame: Up to Day 7
measure: Adverse Events
timeFrame: Up to Day 43
Secondary outcomes:
measure: AUC
timeFrame: Up to Day 7
measure: AUC
timeFrame: Up to Day 34
measure: Cmax
timeFrame: Up to Day 7
measure: Cmax
timeFrame: Up to Day 34
measure: T1/2
timeFrame: Up to Day 7
measure: T1/2
timeFrame: Up to Day 34
measure: Tmax
timeFrame: Up to Day 7
measure: Tmax
timeFrame: Up to Day 34
measure: IL-17A
timeFrame: Up to Day 7
measure: IL-17A
timeFrame: Up to Day 29
measure: Beta Defensin-2
timeFrame: Up to Day 29
measure: IL-19
timeFrame: Up to Day 29
measure: Psoriasis Area and Severity Index (PASI)
timeFrame: Up to Day 43
measure: Target Lesion Severity Score (TLSS)
timeFrame: Up to Day 43
Other outcomes:
Locations:
city: Miami
country: United States
facility: Ascletis Clinical Site
state: Florida
Study officials:
References: