A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ABS-1230 Given Orally Compared With Placebo in Healthy Participants Aged 18 to 55 Years

This is a Phase 1a, first-in-human, placebo-controlled study consisting of 3 parts.

Part 1 is a single ascending dose (SAD) study in up to 32 participants consisting of a screening period of up to 28 days prior to a single dose of ABS-1230 or placebo, with follow-up 7 days and 14 days after dosing.

Part 2 is a multiple ascending dose (MAD) study in up to 30 participants consisting of a screening period of up to 28 days, followed by ABS-1230 or placebo once daily for 14 days, with follow-up 7 days and 14 days after dosing is completed.

Part 3 is a food effect (FE) study in 12 participants consisting of two doses of ABS-1230 under fasted and fed conditions and in combination with omeprazole with follow-up 7 days and 14 days after dosing is completed.

Inclusion criteria

• Age 18 to 55 years, inclusive
• Body mass index greater than or equal to 18 to less than or equal to 32 kg/m2
• Medically healthy with no clinically significant medical history, physical examination, vital sign, standard 12-lead ECG, chemistry, hematology, urinalysis, or coagulation results at Screening as deemed by the Investigator
• Male and female subjects must use adequate birth control and agree not to donate sperm or eggs for the time periods specified in the protocol

Exclusion criteria

• Positive result for HIV, HBV, or HCV
• History of malignancy other than treated basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix
• History of alcoholism or recreational drug use within 2 years or a positive alcohol or tobacco test result at screening or first check-in visit
• For female participants, must not be pregnant, breastfeeding, or seeking to become pregnant while in the study