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
Ascletis Pharma (China) Co., Limited
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
- Age range
- 18–65 years
- Sex
- All
- 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 clinic…
Interventions
- DrugASC50 tablets or matching placebo
Drug: ASC50 administered orally Drug: Placebo administered orally
Location
- Ascletis Clinical SiteMiami, Florida