KCNT1-Related EpilepsyPhase 1NCT07156201
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
A Phase 1 study testing ABS-1230, Omeprazole and Voriconazole in people with KCNT1-Related Epilepsy, run by Actio Biosciences, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- KCNT1-Related Epilepsy
- What is being tested?
- ABS-1230, Omeprazole and Voriconazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteAustralia
- Study dates
- 28 Aug 2025to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Scientia Clinical Research
Sydney, New South Wales
Christopher Argent, MD, (+61) 2 9382 5800, christopher.argent@scientiaclinicalresearch.com.au
Christopher Argent, MD
About this study
Official 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
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.
Read the 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 40 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.
Part 4 is a drug-drug interaction (DDI) study in 10 participants consisting of doses of ABS-1230 in combination with voriconazole, with follow-up 15 days after dosing is completed.
- Conditions
- KCNT1-Related Epilepsy
- Being tested
- ABS-1230, Placebo, Omeprazole, Voriconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABS-1230Drug
ABS-1230
PlaceboDrug
Placebo
OmeprazoleDrug
Omeprazole
VoriconazoleDrug
Voriconazole
| Study group | Role | What they receive |
|---|---|---|
| ABS-1230 Single Dose | Experimental | Single doses of ABS-1230 Receives: Drug: ABS-1230 |
| ABS-1230 Multiple Doses | Experimental | Multiple doses of ABS-1230 Receives: Drug: ABS-1230 |
| Placebo Single Dose | Placebo comparator | Single doses of placebo Receives: Drug: Placebo |
| Placebo Multiple Doses | Placebo comparator | Multiple doses of placebo Receives: Drug: Placebo |
| ABS-1230 Singe Dose + Omeprazole | Experimental | Single doses of ABS-1230 + omeprazole Receives: Drug: ABS-1230; Drug: Omeprazole |
| ABS-1230 Singe Dose + Voriconazole | Experimental | Single doses of ABS-1230 + voriconazole Receives: Drug: ABS-1230; Drug: Voriconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability (incidence, severity, and dose-relationship of adverse events)
To assess safety and tolerability of ABS-1230 following single and multiple oral administration by determining the incidence, severity, and dose-relationship of adverse events
Measured: 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)
To assess safety and tolerability of ABS-1230 following single and multiple oral administration by determining the incidence, severity, and dose-relationship of clinically significant laboratory changes
Measured: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
Secondary outcomes (8)
Maximum Plasma Concentration [Cmax] After Single Dose of ABS-1230
To evaluate the pharmacokinetics of single dose of ABS-1230
Measured: Measured from Day 1 to End of Study or Early Termination (up to 2 weeks)
Maximum Plasma Concentration [AUCinf] After Single Dose of ABS-1230
To evaluate the pharmacokinetics of single dose of ABS-1230
Measured: Measured from Day 1 to End of Study or Early Termination (up to 2 weeks)
Maximum Plasma Concentration [Cmax] After Multiple Doses of ABS-1230
To evaluate the pharmacokinetics of multiple doses of ABS-1230
Measured: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
Maximum Plasma Exposure [AUCtau] After Multiple Doses of ABS-1230
To evaluate the pharmacokinetics of multiple doses of ABS-1230
Measured: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
Maximum Plasma Concentration [Cmax] After Fed, Fasted and in Combination with Omeprazole Doses of ABS-1230
To evaluate the pharmacokinetics of fed, fasted, and in combination with omeprazole doses of ABS-1230
Measured: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
Maximum Plasma Exposure [AUCtau] After Fed, Fasted and in Combination with Omeprazole Doses of ABS-1230
To evaluate the pharmacokinetics of fed, fasted, and in combination with omeprazole doses of ABS-1230
Measured: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
Maximum Plasma Concentration [Cmax] of ABS-1230 in Combination with Voriconazole
To evaluate the pharmacokinetics ABS-1230 in combination with voriconazole
Measured: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
Maximum Plasma Exposure [AUCtau] of ABS-1230 in Combination with Voriconazole
To evaluate the pharmacokinetics ABS-1230 in combination with voriconazole
Measured: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start28 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KCNT1-Related EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Actio Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Actio Bioscences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156201
- Sponsor's protocol ID
- ABS1230-1001
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07156201
- Acronym / sponsor ID
- ABS1230-1001
- Conditions
- KCNT1-Related Epilepsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Actio Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 40 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.
Part 4 is a drug-drug interaction (DDI) study in 10 participants consisting of doses of ABS-1230 in combination with voriconazole, with follow-up 15 days after dosing is completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ABS-1230 Single Dose | Experimental | Drug: ABS-1230Single doses of ABS-1230 |
| ABS-1230 Multiple Doses | Experimental | Drug: ABS-1230Multiple doses of ABS-1230 |
| Placebo Single Dose | Placebo comparator | Drug: PlaceboSingle doses of placebo |
| Placebo Multiple Doses | Placebo comparator | Drug: PlaceboMultiple doses of placebo |
| ABS-1230 Singe Dose + Omeprazole | Experimental | Drug: ABS-1230, Drug: OmeprazoleSingle doses of ABS-1230 + omeprazole |
| ABS-1230 Singe Dose + Voriconazole | Experimental | Drug: ABS-1230, Drug: VoriconazoleSingle doses of ABS-1230 + voriconazole |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABS-1230ABS-1230 | Drug | ABS-1230 Multiple Doses, ABS-1230 Singe Dose + Omeprazole, ABS-1230 Singe Dose + Voriconazole, ABS-1230 Single Dose |
| PlaceboPlacebo | Drug | Placebo Multiple Doses, Placebo Single Dose |
| OmeprazoleOmeprazole | Drug | ABS-1230 Singe Dose + Omeprazole |
| VoriconazoleVoriconazole | Drug | ABS-1230 Singe Dose + Voriconazole |
Primary outcome
Safety and tolerability (incidence, severity, and dose-relationship of adverse events)
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
To assess safety and tolerability of ABS-1230 following single and multiple oral administration by determining the incidence, severity, and dose-relationship of adverse events
Safety and tolerability (incidence, severity, and dose-relationship of clinically significant changes in laboratory parameters)
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
To assess safety and tolerability of ABS-1230 following single and multiple oral administration by determining the incidence, severity, and dose-relationship of clinically significant laboratory changes
8 secondary outcomes
Maximum Plasma Concentration [Cmax] After Single Dose of ABS-1230
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 2 weeks)
Maximum Plasma Concentration [AUCinf] After Single Dose of ABS-1230
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 2 weeks)
Maximum Plasma Concentration [Cmax] After Multiple Doses of ABS-1230
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
Maximum Plasma Exposure [AUCtau] After Multiple Doses of ABS-1230
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
Maximum Plasma Concentration [Cmax] After Fed, Fasted and in Combination with Omeprazole Doses of ABS-1230
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
Maximum Plasma Exposure [AUCtau] After Fed, Fasted and in Combination with Omeprazole Doses of ABS-1230
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
Maximum Plasma Concentration [Cmax] of ABS-1230 in Combination with Voriconazole
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
Maximum Plasma Exposure [AUCtau] of ABS-1230 in Combination with Voriconazole
Time frame: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Actio Bioscences, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABS-1230, Omeprazole and Voriconazole in people with KCNT1-Related Epilepsy, run by Actio Biosciences, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Actio Biosciences, Inc. (+1 (858) 679-5891, info@actiobiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (incidence, severity, and dose-relationship of adverse events) (time frame: Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.