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A Study to Investigate the Safety of AB680 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03677973
Recruitment Status : Completed
First Posted : September 19, 2018
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Arcus Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE September 18, 2018
First Posted Date  ICMJE September 19, 2018
Last Update Posted Date February 11, 2020
Actual Study Start Date  ICMJE October 16, 2018
Actual Primary Completion Date August 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2018)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2018)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Investigate the Safety of AB680 in Healthy Volunteers
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: AB680
    AB680 is a Cluster of Differentiation (CD)73 Inhibitor
  • Other: Placebo
    Matching Placebo
Study Arms  ICMJE
  • 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.
    Intervention: Drug: AB680
  • 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.
    Intervention: Other: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2019)
64
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2018)
16
Actual Study Completion Date  ICMJE August 18, 2019
Actual Primary Completion Date August 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03677973
Other Study ID Numbers  ICMJE AB680CSP0001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arcus Biosciences, Inc.
Study Sponsor  ICMJE Arcus Biosciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Arcus Biosciences, Inc.
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP