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

Actio Biosciences, Inc.

Status and phase: Enrolling; Phase 1

Conditions: KCNT1-Related Epilepsy

Treatments: Drug: Placebo; Drug: ABS-1230; Drug: Omeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT07156201

ABS1230-1001

Details and patient eligibility

About

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.

Full 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 32 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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74 participants in 5 patient groups, including a placebo group

ABS-1230 Single Dose

Experimental group

Description:

Single doses of ABS-1230

Treatment:

Drug: ABS-1230

ABS-1230 Multiple Doses

Experimental group

Description:

Multiple doses of ABS-1230

Treatment:

Drug: ABS-1230

Placebo Single Dose

Placebo Comparator group

Description:

Single doses of placebo

Treatment:

Drug: Placebo

Placebo Multiple Doses

Placebo Comparator group

Description:

Multiple doses of placebo

Treatment:

Drug: Placebo

ABS-1230 Singe Dose + Omeprazole

Experimental group

Description:

Single doses of ABS-1230 + omeprazole

Treatment:

Drug: Omeprazole

Drug: ABS-1230