• In this phase 1a dose-ranging study of ABI-H2158 in healthy human volunteers, ABI-H2158 was safe and
well tolerated following single ascending doses of 5 mg, 25 mg, 100 mg (fasted and fed), 300 mg, and
500 mg PO QD (SAD) and 300 mg PO QD × 10 (MAD)
• No significant food effect was seen when ABI-H2158 100 mg was administered with a standardized
high-fat meal
• There was no increase in the number or severity of TEAEs with increase in dose, and no pattern of clinical
safety or laboratory abnormalities was observed within or across any cohorts
• Human PK parameters suggested low to moderate volunteer-to-volunteer variability
• Trough liver concentration are projected to achieve exposures in excess of the in vitro EC90
levels needed
to inhibit both HBV replication and cccDNA establishment with QD administrat