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
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: KCNT1-Related Epilepsy
In brief
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.
Key facts
- Study ID
- NCT07156201
- Run by
- Actio Biosciences, Inc.
- People needed
- 92
- Starts
- 2025-08-28
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-08-07
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Scientia Clinical Research — Sydney, New South Wales, Australia (enrolling)
Full record on ClinicalTrials.gov
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