Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: AB680 Other: Placebo Phase 1

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 16, 2018
Actual Primary Completion Date : August 18, 2019
Actual Study Completion Date : August 18, 2019
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 Drug: AB680
AB680 is a Cluster of Differentiation (CD)73 Inhibitor
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.
 Other: Placebo
Matching Placebo


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677973


Locations
Layout table for location information
Australia, Victoria
Melbourne, VIC
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Arcus Biosciences, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Arcus Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT03677973    
Other Study ID Numbers: AB680CSP0001
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No