| Interventions |
Accro Bioscience is developing AC-101, a potent and selective oral small molecule inhibitor of RIPK2, indicated for treatment of inflammatory bowel disease (IBD). Investigational Product (IP): AC-101 Dose: 100 mg Dosage Form: Tablet Mode of Administration: Oral An open panel of 12 subjects will receive single dose of 100 mg of AC-101 under both fed and fasted conditions in a two-period crossover study. In the study, 6 subjects will receive a single administration of AC-101 under fasted condition in period 1 Day 1 and receive another administration of AC-101 after a high-fat meal in period 2 Day 5, after a wash out period of 3 day. For the other 6 subjects, the administration of AC-101in period 1 will be carried out under a fed condition, the administration of AC-101 in period 2 will be carried out at fasted condition. The subjects will have a total of 7 overnight stays (admission on Day -1 until Day 7) and will have a follow up visit on Day 14. A high-fat (approximately 50 percent of total caloric content of the meal) and high-calorie (approximately 800 to 1000 calories) meal will provide to the subject 30 min prior to dosing. This test meal should derive approximately 150, 250, and 500-600 calories from protein, carbohydrate, and fat, respectively. The participants are dosed at the site, they will receive study treatment directly from the Investigator or designee, under medical supervision. Immediately after dose administration, visual inspection of the mouth and hands will be performed for each subject. The date and time of each dose administered will be recorded in the source documents. The dose of study treatment and study participant identification will be confirmed at the time of dosing by a member of the study site staff other than th |