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Completed

NCT Number: NCT03677973

A Study to Investigate the Safety 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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Melbourne, VIC

Melbourne, Victoria, 3004, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

AB680

Drug

AB680 is a Cluster of Differentiation (CD)73 Inhibitor

Placebo

Other

Matching Placebo

Primary 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.

  2. AB680 Peak Plasma Concentration (Cmax)

    Time frame: 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.

  3. AB680 Time of Peak Concentration (Tmax)

    Time frame: 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.

Secondary outcomes

  1. Pharmacodynamic (PD) Effects of AB680

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

    Enzymatic Activity of CD73 Measured in Participant Blood Samples.

  2. Plasma Levels of Adenosine

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

    Amount of Adenosine 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- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB680 in Healthy Volunteers

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 19, 2018
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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