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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABS-1230 Single Dose | Experimental | Single doses of ABS-1230 |
|
| ABS-1230 Multiple Doses | Experimental | Multiple doses of ABS-1230 |
|
| Placebo Single Dose | Placebo Comparator | Single doses of placebo |
|
| Placebo Multiple Doses | Placebo Comparator | Multiple doses of placebo |
|
| ABS-1230 Singe Dose + Omeprazole | Experimental | Single doses of ABS-1230 + omeprazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABS-1230 | Drug | ABS-1230 |
|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration [Cmax] 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 [AUCtau] After Single Dose of ABS-1230 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Actio Biosciences, Inc. | Contact | +1 (858) 679-5891 | info@actiobiosciences.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Actio Bioscences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientia Clinical Research | Recruiting | Sydney | New South Wales | Australia |
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| Placebo | Drug | Placebo |
|
| Omeprazole | Drug | Omeprazole |
|
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] 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 [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] After Fed, Fasted and in Combination with Omeprazole Doses of ABS-1230 | To evaluate the pharmacokinetics of 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) |
| Maximum Plasma Concentration [AUCtau] After Fed, Fasted and in Combination with Omeprazole Doses of ABS-1230 | To evaluate the pharmacokinetics of 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) |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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