Overview Study details Eligibility Things to know Research Study plan

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Overview Study details Eligibility Things to know Research Study plan

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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

PHASE1RECRUITING

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.

Study details:

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, with follow-up 7 days and 14 days after dosing is completed.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

Study type

TREATMENT

Phase

PHASE1

Study ID

NCT07156201

Intervention or treatment

DRUG: ABS-1230

DRUG: Placebo

Conditions

KCNT1-Related Epilepsy

Condition: KCNT1-Related Epilepsy
DRUG: ABS-1230 and other drugs
Sydney, New South Wales, Australia
Sponsor: Actio Biosciences, Inc.

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Are you running this trial?

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Research sites nearby

Closest Location:

Scientia Clinical Research

Select from list below to view details:

Scientia Clinical Research
Sydney, New South Wales, Australia

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Who is running the clinical trial?

ABI

Actio Biosciences, Inc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: ABS-1230 Single Dose Single doses of ABS-1230	Drug: ABS-1230
EXPERIMENTAL: ABS-1230 Multiple Doses Multiple doses of ABS-1230	Drug: ABS-1230
PLACEBO_COMPARATOR: Placebo Single Dose Single doses of placebo	Drug: Placebo
PLACEBO_COMPARATOR: Placebo Multiple Doses Multiple doses of placebo	Drug: Placebo
EXPERIMENTAL: ABS-1230 Singe Dose + Omeprazole Single doses of ABS-1230 + omeprazole	Drug: ABS-1230, Drug: Omeprazole
EXPERIMENTAL: ABS-1230 Singe Dose + Voriconazole Single doses of ABS-1230 + voriconazole	Drug: ABS-1230, Drug: Voriconazole

What is the study measuring?

Primary Outcome

Measure	Description	Time Frame
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 Outcome

Measure	Description	Time Frame
Maximum Plasma Concentration [Cmax and AUCtau] After Single Dose of ABS-1230	To evaluate the pharmacokinetics of single dose of ABS-1230	Measured from Day 1 to End of Study or Early Termination (up to 2 weeks)
Maximum Plasma Concentration [Cmax and AUCtau] After Multiple Doses of ABS-1230	To evaluate the pharmacokinetics of multiple doses of ABS-1230	Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)
Maximum Plasma Concentration [Cmax and AUCtau] After Fed and Fasted Doses of ABS-1230	To evaluate the pharmacokinetics of fed and fasted doses of ABS-1230	Measured from Day 1 to End of Study or Early Termination (up to 4 weeks)

Are you running this trial?If you're a clinic or sponsor, you can claim this study.

Claim this trial

References

Clinical Trials Gov: 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

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