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
| Registry | NCT07156201 |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 92 (Estimated) |
| Sponsor | Actio Biosciences, Inc. (Industry) |
| Conditions | KCNT1-Related Epilepsy |
| Interventions | ABS-1230, Placebo, Omeprazole, Voriconazole (Drug) |
| Dates | start 2025-08-28, primary completion 2026-12-01 (estimated), completion 2026-12-01 (estimated), first posted 2025-09-05, last updated 2026-08-07 |
| Locations | 1 site in Australia |
Related Papers Related Patents Related Grants Related Experts
All trials for KCNT1-Related Epilepsy All trials of ABS-1230 All trials of Placebo
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ABS-1230 Single Dose | Experimental | Drug: ABS-1230 | Single doses of ABS-1230 |
| ABS-1230 Multiple Doses | Experimental | Drug: ABS-1230 | Multiple doses of ABS-1230 |
| Placebo Single Dose | Placebo comparator | Drug: Placebo | Single doses of placebo |
| Placebo Multiple Doses | Placebo comparator | Drug: Placebo | Multiple doses of placebo |
| ABS-1230 Singe Dose + Omeprazole | Experimental | Drug: ABS-1230; Drug: Omeprazole | Single doses of ABS-1230 + omeprazole |
| ABS-1230 Singe Dose + Voriconazole | Experimental | Drug: ABS-1230; Drug: Voriconazole | Single doses of ABS-1230 + voriconazole |
Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Scientia Clinical Research | Sydney, New South Wales | Australia | Recruiting |