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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03677973
Registration number
NCT03677973
Ethics application status
Date submitted
18/09/2018
Date registered
19/09/2018
Titles & IDs
Public title
A Study to Investigate the Safety of AB680 in Healthy Volunteers
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Scientific 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
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Secondary ID [1]
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AB680CSP0001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AB680
Other interventions - Placebo
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.
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.
Treatment: Drugs: AB680
AB680 is a Cluster of Differentiation (CD)73 Inhibitor
Other interventions: Placebo
Matching Placebo
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants with Treatment Emergent Adverse Events (TEAEs).
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Assessment method [1]
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Number of Participants with TEAEs as Assessed by CTCAE v5.0.
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Timepoint [1]
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From First Dose Date to 15 Days After the Last Dose of AB680.
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Primary outcome [2]
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AB680 Peak Plasma Concentration (Cmax)
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Assessment method [2]
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Cmax as Measured by the Area Under Concentration-Time Curve from Plasma Collection and Analysis.
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Timepoint [2]
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From First Dose Date to 15 Days After the Last Dose of AB680.
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Primary outcome [3]
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AB680 Time of Peak Concentration (Tmax)
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Assessment method [3]
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Tmax as Measured by the Time to Maximum Concentration-Time Curve from Plasma Collection and Analysis.
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Timepoint [3]
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From First Dose Date to 15 Days After the Last Dose of AB680.
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Secondary outcome [1]
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Pharmacodynamic (PD) Effects of AB680
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Assessment method [1]
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Enzymatic Activity of CD73 Measured in Participant Blood Samples.
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Timepoint [1]
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From First Dose Date to 15 Days After the Last Dose of AB680.
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Secondary outcome [2]
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Plasma Levels of Adenosine
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Assessment method [2]
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Amount of Adenosine Measured in Participant Blood Samples.
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Timepoint [2]
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From First Dose Date to 15 Days After the Last Dose of AB680.
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/10/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/08/2019
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Sample size
Target
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Accrual to date
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Final
64
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Melbourne, VIC - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Arcus Biosciences, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/study/NCT03677973
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://trials.arcusbio.com/our-transparency-policy
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03677973