RecruitingPhase 1

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

Australia74 participantsStarted 2025-08-28

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and tolerability (incidence, severity, and dose-relationship of adverse events)

Timeframe: 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)

Timeframe: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)

Trial details

NCT IDNCT07156201

SponsorActio Biosciences, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03

Contact for this trial

Actio Biosciences, Inc.

+1 (858) 679-5891 info@actiobiosciences.com

View on ClinicalTrials.gov More KCNT1-Related Epilepsy trials

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Safety and tolerability (incidence, severity, and dose-relationship of adverse events)

Timeframe: 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)

Timeframe: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)