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New epilepsy drug candidate enters first human safety tests

NCT ID NCT07156201

Knowledge-focused Sponsor: Actio Biosciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 3 times

Summary

This early-stage trial is testing a new drug called ABS-1230 in 74 healthy adults to see if it is safe and how the body processes it. The drug is being developed for a rare type of epilepsy caused by changes in the KCNT1 gene. Participants will receive either the drug or a placebo, and researchers will monitor for side effects and measure drug levels in the blood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ABS-1230
What this could lead to
If this trial shows ABS-1230 is safe, it could pave the way for testing it as a treatment for KCNT1-related epilepsy.
What could go wrong
This is a very early, small study in healthy people, not patients. It only looks at safety and how the drug moves through the body, not whether it works for epilepsy. Many drugs fail at this stage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 92 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

developmental and epileptic encephalopathy, 14

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

KCNT1-related epilepsy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Scientia Clinical Research

    RECRUITING

    Sydney, New South Wales, Australia

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