A Study to Investigate the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers

A Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Investigate the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers

A Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Investigate the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers.

Study Overview

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

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia
      • Nucleus Network

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Male or female participants aged 18 to 55 years, inclusive, at screening
• Body mass index 18 to 32 kilograms/m^2 inclusive
• 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: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active: Dose Escalation; 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; AB680 is a Cluster of Differentiation (CD)73 Inhibitor
Placebo Comparator: Placebo: Dose Escalation; Participants will receive matching placebo as a single oral dose. Assignment to receive matching placebo will be random.	Other: Placebo; Matching Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary 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

Other Outcome Measures

Outcome Measure	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]

Collaborators and Investigators

• Sponsor: Arcus Biosciences, Inc.

Publications and helpful links

Helpful Links

• ARC-11 - Lay Summary (English Version)

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Actual): September 22, 2021
• Study Completion (Actual): September 22, 2021

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 5, 2020

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: ARC-11

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