Comparison of ABBV‐552 Safety and Pharmacokinetics in Healthy Asian and Western Adults

Abstract

ABBV‐552, a positive modulator of synaptic vesicle glycoprotein 2A (SV2A), was under investigation as a treatment for cognitive impairment related to Alzheimer's disease. This Phase 1, multicenter, open‐label, parallel cohort study (NCT05686980) was conducted to examine the pharmacokinetics (PK), safety, and tolerability of ABBV‐552 in healthy adult Japanese and Han Chinese participants and to compare PK and safety findings with healthy adult Western participants from previous studies. Japanese participants in Cohort 1 (N = 10) received three ascending single oral doses (5, 15, and 40 mg) of ABBV‐552 with a washout of 7 days between doses. Han Chinese participants in Cohort 2 (N = 7) received a single oral dose of 40 mg ABBV‐552. After a single oral dose of 40 mg ABBV‐552, PK was comparable between both cohorts. Additionally, the range of individual ABBV‐552 concentrations and mean 24‐h profiles were comparable with historical data in healthy adult Western participants. In this small study population, single doses of ABBV‐552 were well tolerated at all tested doses. Common adverse events reported were dizziness (39%), somnolence (11%), and fatigue (11%). No unique safety signals following single dose ABBV‐552 administration were observed in the Japanese or Han Chinese populations examined compared with the previously examined Western population.