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Completed

NCT Number: NCT04575311

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network

Melbourne, Victoria, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AB680

Drug

AB680 is a Cluster of Differentiation (CD)73 Inhibitor

Placebo

Other

Matching Placebo

Primary outcomes

  1. AB680 Peak Plasma Concentration (Cmax)

    Time frame: Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680

    Cmax as measured by the Area Under Concentration-Time Curve from Plasma Collection and Analysis.

  2. AB680 Time of Peak Concentration (Tmax)

    Time frame: Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680

    Tmax as measured by the Time to Maximum Concentration-Time Curve from Plasma Collection and Analysis

  3. 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

Secondary outcomes

  1. Number of participants with Treatment Emergent Adverse Events (TEAEs)

    Time frame: From First Dose Date to 15 Days After the Last Dose of AB680

    Number of participants with TEAEs as assessed by CTCAE v5.0.

Other outcomes

  1. Pharmacodynamic (PD) Effects of AB680

    Time frame: Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680]

    Enzymatic Activity of CD73 measured in participant blood samples.

Sponsors and collaborators

Lead sponsor

Arcus Biosciences, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 5, 2020
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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