A Phase 1 interventional study of AB680 and Placebo in Healthy Volunteers, sponsored by Arcus Biosciences, Inc.. Completed at 1 site in Australia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-24.
Sponsored by Arcus Biosciences, Inc. · Phase 1, Interventional, and Treatment
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.
Arcus Biosciences, Inc. is the lead sponsor of 32 studies on the registry; 4 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive a single oral dose of AB680 at one of two ascending dose levels. Assignment to receive AB680 will be random.
Drug: AB680
Participants will receive matching placebo as a single oral dose. Assignment to receive matching placebo will be random.
Other: Placebo
AB680 is a Cluster of Differentiation (CD)73 Inhibitor
Matching Placebo
AB680 Peak Plasma Concentration (Cmax)
Cmax as measured by the Area Under Concentration-Time Curve from Plasma Collection and Analysis.
Time frame: 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
Time frame: 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
Time frame: Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Number of participants with TEAEs as assessed by CTCAE v5.0.
Time frame: From First Dose Date to 15 Days After the Last Dose of AB680
Pharmacodynamic (PD) Effects of AB680
Enzymatic Activity of CD73 measured in participant blood samples.
Time frame: Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680]
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Arcus Biosciences, Inc.