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
NCT ID: NCT07156201
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
74 participants
INTERVENTIONAL
2025-08-28
2026-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ABS-1230 Single Dose
Single doses of ABS-1230
ABS-1230
ABS-1230
ABS-1230 Multiple Doses
Multiple doses of ABS-1230
ABS-1230
ABS-1230
Placebo Single Dose
Single doses of placebo
Placebo
Placebo
Placebo Multiple Doses
Multiple doses of placebo
Placebo
Placebo
ABS-1230 Singe Dose + Omeprazole
Single doses of ABS-1230 + omeprazole
ABS-1230
ABS-1230
Omeprazole
Omeprazole
Interventions
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ABS-1230
ABS-1230
Placebo
Placebo
Omeprazole
Omeprazole
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Actio Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Actio Bioscences, Inc.
Locations
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Scientia Clinical Research
Sydney, New South Wales, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ABS1230-1001
Identifier Type: -
Identifier Source: org_study_id
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