A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ASC50 Tables in Healthy Participants and Participants With Plaque Psoriasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ASC50 tablets or matching placebo.
- Who it may be relevant to
- Registry conditions: Plaque Psoriasis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug ASC50 tablets or matching placebo
Drug: ASC50 administered orally Drug: Placebo administered orally
Primary outcome measures
- Adverse Events [Time frame: Up to Day 7]
- Adverse Events [Time frame: Up to Day 43]
Secondary outcome measures (12)
- AUC [Time frame: Up to Day 7]
- AUC [Time frame: Up to Day 34]
- Cmax [Time frame: Up to Day 7]
- Cmax [Time frame: Up to Day 34]
- T1/2 [Time frame: Up to Day 7]
- T1/2 [Time frame: Up to Day 34]
- Tmax [Time frame: Up to Day 7]
- Tmax [Time frame: Up to Day 34]
- IL-17A [Time frame: Up to Day 7]
- IL-17A [Time frame: Up to Day 29]
- Beta Defensin-2 [Time frame: Up to Day 29]
- IL-19 [Time frame: Up to Day 29]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Ascletis Clinical Site — Miami
Identifiers
NCT: NCT07024602 · ASC50-101