A Study to Investigate the Safety of AB680 in Healthy Volunteers
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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
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Sponsor:
Arcus Biosciences, Inc.
Information provided by (Responsible Party):
Arcus Biosciences, Inc.
Tracking Information | |||||
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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 |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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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. |
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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 |
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Condition ICMJE | Healthy Volunteers | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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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. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
64 | ||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |