Part B: randomized, double-blind, placebo-controlled, multiple-ascending dose phase
Cohort B comprised 22 participants in two cohorts, B1 and B2, with 8 and 3 participants in each cohort randomized to receive GB1211 or placebo, respectively. Following review of safety, tolerability, and PK data from cohorts A1–A6, participants received twice-daily doses (BID) under fasted conditions on days 1–9 and a final single dose in the morning of day 10. Participants in B1 received 50 mg GB1211 (1 × 50 mg capsule) BID or placebo and B2 received 100 mg GB1211 (2 × 50 mg capsules) BID or placebo. There was one treatment period and all participants stayed at the CRU from day − 1 until the morning of day 11 (24 h after the final dose on day 10). All were to return for a follow-up visit 5–7 days after their final dose.