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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07156201




Registration number
NCT07156201
Ethics application status
Date submitted
25/08/2025
Date registered
5/09/2025
Date last updated
5/09/2025

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 0 0
ABS1230-1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
KCNT1-Related Epilepsy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABS-1230
Treatment: Drugs - Placebo

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


Treatment: Drugs: ABS-1230
ABS-1230

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability (incidence, severity, and dose-relationship of adverse events)
Timepoint [1] 0 0
Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
Primary outcome [2] 0 0
Safety and tolerability (incidence, severity, and dose-relationship of clinically significant changes in laboratory parameters)
Timepoint [2] 0 0
Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
Secondary outcome [1] 0 0
Maximum Plasma Concentration [Cmax and AUCtau] After Single Dose of ABS-1230
Timepoint [1] 0 0
Measured from Day 1 to End of Study or Early Termination (up to 2 weeks)
Secondary outcome [2] 0 0
Maximum Plasma Concentration [Cmax and AUCtau] After Multiple Doses of ABS-1230
Timepoint [2] 0 0
Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
Secondary outcome [3] 0 0
Maximum Plasma Concentration [Cmax and AUCtau] After Fed and Fasted Doses of ABS-1230
Timepoint [3] 0 0
Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2026
Actual
Sample size
Target
74
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Actio Biosciences, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Actio Bioscences, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Actio Biosciences, Inc.
Address 0 0
Country 0 0
Phone 0 0
+1 (858) 679-5891
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07156201