| 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 Dosage Form: Tablet Mode of Administration: Oral Part 1 Single Ascending Dose: A total of 40 participants in 5 dose levels including 50, 100, 200, 400 and 600 mg will be evaluated; All doses will be administered after an overnight fast of at least 10 hours for all Cohorts of Part 1 8 Participants 6 (study drug): 2 (placebo) in each cohort. Cohort 1: 50mg AC-101 single oral administration on Day 1 Cohort 2: 100mg AC-101 single oral administration on Day 1 Cohort 3: 200mg AC-101 single oral administration on Day 1 Cohort 4: 400mg AC-101 single oral administration on Day 1 Cohort 5: 600mg AC-101 single oral administration on Day 1 Part 3 Multiple Ascending Dose: A total of 30 participants in 3 dose levels including 50, 100, 200 mg will be evaluated; All doses will be administered after an overnight fast of at least 10 hours for all cohorts of Part 3 10 Participants 8 (study drug): 2 (placebo) in Cohort 1, Cohort 2 and Cohort 3 Cohort 1: 50mg AC-101 once daily for a consecutive 7 days i.e., Day 1 to Day 7 Cohort 2: 100mg AC-101 once daily for a consecutive 7 days i.e., Day 1 to Day 7 Cohort 3: 200mg AC-101 once daily for a consecutive 7 days i.e., Day 1 to Day 7 All doses of study drug will be administered orally with approximately 240mL of room temperature water. Water consumption will be restricted from 1 h prior to dosing until 2 h after dosing, when water will be given to maintain adequate hydration. For some participants, they may require extra water. Providing additional water eg. 100mL to be allowed and documented |