This first in human trial will evaluate the safety, tolerability, and pharmacokinetics of single ascending doses, multiple ascending doses, and fed and fasted doses of ABS-1230 given orally compared with placebo in adult healthy participants.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
74
Scientia Clinical Research
Sydney, New South Wales, Australia
RECRUITINGSafety and tolerability (incidence, severity, and dose-relationship of adverse events)
To assess safety and tolerability of ABS-1230 following single and multiple oral administration by determining the incidence, severity, and dose-relationship of adverse events
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
Safety and tolerability (incidence, severity, and dose-relationship of clinically significant changes in laboratory parameters)
To assess safety and tolerability of ABS-1230 following single and multiple oral administration by determining the incidence, severity, and dose-relationship of clinically significant laboratory changes
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
Maximum Plasma Concentration [Cmax] After Single Dose of ABS-1230
To evaluate the pharmacokinetics of single dose of ABS-1230
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 2 weeks)
Maximum Plasma Concentration [AUCtau] After Single Dose of ABS-1230
To evaluate the pharmacokinetics of single dose of ABS-1230
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 2 weeks)
Maximum Plasma Concentration [Cmax] After Multiple Doses of ABS-1230
To evaluate the pharmacokinetics of multiple doses of ABS-1230
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
Maximum Plasma Concentration [AUCtau] After Multiple Doses of ABS-1230
To evaluate the pharmacokinetics of multiple doses of ABS-1230
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
Maximum Plasma Concentration [Cmax] After Fed, Fasted and in Combination with Omeprazole Doses of ABS-1230
To evaluate the pharmacokinetics of fed, fasted, and in combination with omeprazole doses of ABS-1230
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
Maximum Plasma Concentration [AUCtau] After Fed, Fasted and in Combination with Omeprazole Doses of ABS-1230
To evaluate the pharmacokinetics of fed, fasted, and in combination with omeprazole doses of ABS-1230
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)