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A Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Investigate the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers.
The study will evaluate minimum of 2 dose levels of AB680 in 8 participants per cohort. Cohorts will be gender-balanced to the extent possible, and will be randomized 3:1, active vs placebo, respectively.
The participants will be closely observed for the first 48 hours following drug administration to monitor the general tolerability of AB680.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active: Dose Escalation | Active Comparator | Participants will receive a single oral dose of AB680 at one of two ascending dose levels. Assignment to receive AB680 will be random. |
|
| Placebo: Dose Escalation | Placebo Comparator | Participants will receive matching placebo as a single oral dose. Assignment to receive matching placebo will be random. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AB680 | Drug | AB680 is a Cluster of Differentiation (CD)73 Inhibitor |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AB680 Peak Plasma Concentration (Cmax) | Cmax as measured by the Area Under Concentration-Time Curve from Plasma Collection and Analysis. | Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680 |
| AB680 Time of Peak Concentration (Tmax) | Tmax as measured by the Time to Maximum Concentration-Time Curve from Plasma Collection and Analysis | Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680 |
| Area under the plasma concentration-time curve from time zero to t hours (AUC 0-t) of AB680 | Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment Emergent Adverse Events (TEAEs) | Number of participants with TEAEs as assessed by CTCAE v5.0. | From First Dose Date to 15 Days After the Last Dose of AB680 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic (PD) Effects of AB680 | Enzymatic Activity of CD73 measured in participant blood samples. | Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680] |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Melbourne | Victoria | Australia |
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| Label | URL |
|---|---|
| ARC-11 - Lay Summary (English Version) | View source |
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Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
For more information, please visit our website.
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| ID | Term |
|---|---|
| C000723779 | quemliclustat |
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| Placebo |
| Other |
Matching Placebo |
|