Status:
RECRUITING
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
Lead Sponsor:
Actio Biosciences, Inc.
Conditions:
KCNT1-Related Epilepsy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 w...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT07156201
Start Date
August 28 2025
End Date
March 1 2026
Last Update
November 26 2025
Active Locations (1)
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1
Scientia Clinical Research
Sydney, New South Wales, Australia