Plaque Psoriasis
Conditions
Keywords
ASC50, Plaque Psoriasis
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.
Interventions
DRUGASC50 tablets or matching placebo
Drug: ASC50 administered orally Drug: Placebo administered orally
Sponsors
Ascletis Pharma (China) Co., Limited
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Up to Day 7 | Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Up to Day 7 | Evaluate the Peak Plasma Concentration of ASC50 |
| T1/2 | Up to Day 7 | Evaluate the Terminal-Phase Half-Life of ASC50 |
| Tmax | Up to Day 7 | Evaluate the time to reach the maximum concentration of ASC50 |
| IL-17A | Up to Day 7 | Changes in IL-17A after ASC50 administration |
| AUC | Up to Day 7 | Evaluate the Area under the plasma concentration versus time curve of ASC50 |
| IL-19 | Up to Day 29 | Changes in IL-19 after ASC50 administration |
| Psoriasis Area and Severity Index (PASI) | Up to Day 43 | Changes in Psoriasis Area and Severity Index (PASI) after ASC50 treatment. |
| Target Lesion Severity Score (TLSS) | Up to Day 43 | Changes in Target Lesion Severity Score (TLSS)after ASC50 treatment. |
| Beta Defensin-2 | Up to Day 29 | Changes in Beta Defensin-2 after ASC50 administration |
Countries
United States
Contacts
Primary ContactVanessa Wang, MD
Outcome results
None listed