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This is a double-blind, randomized, placebo-controlled, single- and multiple-ascending dose study to investigate the safety, tolerability, and pharmacokinetic profile of AB680 in healthy volunteers.
AB680 will be administered as single and multiple intravenous doses to the healthy volunteers. In each group of 8 participants, 6 will receive AB680 and 2 will receive matching placebo.
The participants will be closely observed to monitor the general tolerability of AB680.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active: Dose Escalation | Active Comparator | Healthy volunteers will receive AB680 as a single intravenous (IV) infusion at 7 dose levels and as multiple IV infusions at 1 dose level. Assignment to receive AB680 or matching placebo will be random. |
|
| Placebo: Dose Escalation | Placebo Comparator | Healthy volunteers will receive matching placebo as a single IV infusion and as multiple IV infusions. Assignment to receive AB680 or 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 |
|---|---|---|
| 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. |
| AB680 Peak Plasma Concentration (Cmax) | Cmax as Measured by the Area Under Concentration-Time Curve from Plasma Collection and Analysis. | 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. | 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. | From First Dose Date to 15 Days After the Last Dose of AB680. |
| Plasma Levels of Adenosine |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Melbourne, VIC | Melbourne | Victoria | 3004 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31334635 | Derived | Bowman CE, da Silva RG, Pham A, Young SW. An Exceptionally Potent Inhibitor of Human CD73. Biochemistry. 2019 Aug 6;58(31):3331-3334. doi: 10.1021/acs.biochem.9b00448. Epub 2019 Jul 23. |
| Label | URL |
|---|---|
| AB680CSP0001 - 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 |
|
Amount of Adenosine Measured in Participant Blood Samples.
| From First Dose Date to 15 Days After the Last Dose of AB680. |