A First-in-Human, Phase 1a, Randomized, Double-Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose and Food Effect Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABS-1230 Administered Orally to Healthy Adults
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:
• 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
Locations
Other Locations
Australia
Scientia Clinical Research
RECRUITING
Sydney
Contact Information
Primary
Actio Biosciences, Inc.
info@actiobiosciences.com
+1 (858) 679-5891
Time Frame
Start Date: 2025-08-28
Estimated Completion Date: 2026-03
Participants
Target number of participants: 74
Treatments
Experimental: ABS-1230 Single Dose
Single doses of ABS-1230
Experimental: ABS-1230 Multiple Doses
Multiple doses of ABS-1230
Placebo_comparator: Placebo Single Dose
Single doses of placebo
Placebo_comparator: Placebo Multiple Doses
Multiple doses of placebo
Experimental: ABS-1230 Singe Dose + Omeprazole
Single doses of ABS-1230 + omeprazole
Related Therapeutic Areas
Sponsors
Leads: Actio Biosciences, Inc.