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

NCT07156201 | Recruiting Phase 1

• 1 other identifier: ABS1230-1001
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

KCNT1-Related Epilepsy

Outcome Measures

Primary Outcomes (2)

• 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 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 from Day 1 to End of Study or Early Termination (up to 4 weeks)

Secondary Outcomes (6)

• Maximum Plasma Concentration [Cmax] After Single Dose of ABS-1230

  Measured from Day 1 to End of Study or Early Termination (up to 2 weeks)

• Maximum Plasma Concentration [AUCtau] After Single Dose of ABS-1230

  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

  Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)

• Maximum Plasma Concentration [AUCtau] After Multiple Doses of ABS-1230

  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

  Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)

Study Arms (5)

ABS-1230 Single Dose

EXPERIMENTAL

Single doses of ABS-1230

Drug: ABS-1230

ABS-1230 Multiple Doses

EXPERIMENTAL

Multiple doses of ABS-1230

Drug: ABS-1230

Placebo Single Dose

PLACEBO COMPARATOR

Single doses of placebo

Drug: Placebo

Placebo Multiple Doses

PLACEBO COMPARATOR

Multiple doses of placebo

Drug: Placebo

ABS-1230 Singe Dose + Omeprazole

EXPERIMENTAL

Single doses of ABS-1230 + omeprazole

Drug: ABS-1230; Drug: Omeprazole

Interventions

ABS-1230 DRUG

ABS-1230

ABS-1230 Multiple Doses; ABS-1230 Singe Dose + Omeprazole; ABS-1230 Single Dose

Placebo DRUG

Placebo

Placebo Multiple Doses; Placebo Single Dose

Omeprazole DRUG

Omeprazole

ABS-1230 Singe Dose + Omeprazole

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Actio Biosciences, Inc.: lead

Study Sites (1)

Scientia Clinical Research

Sydney, New South Wales, Australia

RECRUITING

MeSH Terms

Interventions

Omeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Medical Director

  Actio Bioscences, Inc.

  STUDY DIRECTOR

Central Study Contacts

Actio Biosciences, Inc.

CONTACT

+1 (858) 679-5891; info@actiobiosciences.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 5, 2025
• Study Start: August 28, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)