Oral ABS-1230 versus placebo in healthy adults 18–55

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 will test single and multiple oral doses of ABS-1230 versus placebo in healthy adults to see how safe it is, how well people tolerate it, and how the body absorbs and clears the drug.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Actio Biosciences, Inc. (Industry-sponsored)
• Locations: 1 site (Sydney, New South Wales)
• Trial ID: NCT07156201 on ClinicalTrials.gov

What this trial studies

This Phase 1a, first-in-human, placebo-controlled study uses a three-part design to characterize safety, tolerability, and pharmacokinetics of ABS-1230 in healthy volunteers. Part 1 is a single ascending dose (SAD) cohort of up to 32 participants, Part 2 is a multiple ascending dose (MAD) cohort of up to 30 participants dosed once daily for 14 days, and Part 3 is a food-effect (FE) crossover in 12 participants including co-administration with omeprazole. Participants are closely monitored with clinical exams, ECGs, laboratory tests, and follow-up visits at 7 and 14 days after dosing. Placebo control and dose escalation are used to identify safe dose ranges and characterize how food and a proton-pump inhibitor affect drug exposure.

Who should consider this trial

Good fit: Ideal participants are healthy adults aged 18–55 with a BMI of 18–32 kg/m2, no significant medical history or abnormal screening tests, and agreement to use effective contraception and not donate gametes during the specified periods.

Not a fit: People with KCNT1-related epilepsy and other patients are unlikely to receive direct therapeutic benefit from participation because the study enrolls healthy volunteers and focuses on early safety and dosing.

Why it matters

Potential benefit: If successful, ABS-1230 could become a potential new targeted treatment option for people with KCNT1-related epilepsy by offering an effective medication with a defined safety and dosing profile.

How similar studies have performed: Single- and multiple-ascending-dose and food-effect studies are standard and have successfully characterized safety and pharmacokinetics for many small-molecule drugs, but ABS-1230 itself has no prior human efficacy data.

Eligibility criteria

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

Where this trial is running

Sydney, New South Wales

• Scientia Clinical Research — Sydney, New South Wales, Australia (Recruiting)

Study contacts

• Study coordinator: Actio Biosciences, Inc.

Conditions KCNT1-Related Epilepsy