A Study to Investigate the Safety of AB680 in Healthy Volunteers

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Placebo; Drug: AB680

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Melbourne, VIC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 to 55 years, inclusive, at screening
• Body mass index 18 to 30 kg/m2
• Willing and able to sign informed consent
• Negative tests for hepatitis B surface antigen, anti-hepatitis C virus, and human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening
• Healthy as determined by pre-study screening

Exclusion Criteria:

• History of clinically significant drug and/or food allergies
• Positive drug and alcohol screen at screening and (each) admission to the clinical research center.
• Participation in a drug study within 60 days prior to (the first) drug administration in the current study. Participation in more than 4 other drug studies in the 12 months prior to (the first) drug administration in the current study
• Participants who have significant infection or known inflammatory process on screening or admission

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active: Dose Escalation; 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.	Drug: AB680; AB680 is a Cluster of Differentiation (CD)73 Inhibitor
Placebo Comparator: Placebo: Dose Escalation; 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.	Other: Placebo; Matching Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	Amount of Adenosine Measured in Participant Blood Samples.	From First Dose Date to 15 Days After the Last Dose of AB680.

Collaborators and Investigators

• Sponsor: Arcus Biosciences, Inc.

Publications and helpful links

General Publications

• 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.

Helpful Links

• AB680CSP0001 - Lay Summary (English Version)

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2018
• Primary Completion (Actual): August 19, 2019
• Study Completion (Actual): August 19, 2019

Study Registration Dates

• First Submitted: September 18, 2018
• First Submitted That Met QC Criteria: September 18, 2018
• First Posted (Actual): September 19, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Quemliclustat
• Other Study ID Numbers: AB680CSP0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No