GBS-101 is a single center Phase 1, placebo-controlled, randomized, double blind, first-in-human (FIH), sequential single ascending dose (SAD) study to evaluate the safety, tolerability and PK of GV101 in healthy subjects. 8 healthy subjects wills be enrolled in each of 7 cohorts of the study (50 mg (tablet), 100 mg (tablet), 200 mg (tablet), 400 mg (tablet), 400 mg (liquid), 800 mg (liquid), 1600 mg (liquid). Participants will be randomized in a 3:1 ratio, 1:1 for 2 sentinel subjects and 5: 1 GV101 drug to matching placebo thereafter. Subjects in each cohort will receive a single oral dose of GV101 or matching placebo under fasting conditions. A staggered schedule will be used for each dose level, where 2 sentinel subjects (1 active and 1 placebo) will be dosed first, with the remaining 6 subjects (5 active and 1 placebo) dosed at least 24 hours after the sentinel subjects.~This study of GV101 will provide safety, tolerability, and plasma pharmacokinetic data in healthy individuals. The PK component will characterize the PK of GV101 to inform dosing and may help to correlate exposures treatment-related AEs.
This is a single center Phase 1, placebo-controlled, randomized, double blind, first-in-human (FIH), sequential single ascending dose (SAD) study.