A Study to Investigate the Safety of AB680 in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT03677973|
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : November 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: AB680 Other: Placebo||Phase 1|
AB680 will be administered as a single intravenous dose 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Blind, Randomized, Placebo-Controlled, Single-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB680 in Healthy Volunteers|
|Actual Study Start Date :||October 16, 2018|
|Estimated Primary Completion Date :||March 18, 2019|
|Estimated Study Completion Date :||March 18, 2019|
Active Comparator: Active: Dose Escalation
Healthy volunteers will receive AB680 as a single intravenous (IV) infusion at 2 dose levels. Assignment to receive AB680 or matching placebo will be random.
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. Assignment to receive AB680 or matching placebo will be random.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677973
|Contact: Medical Director||510-694-6200||ClinicalTrialInquiry@arcusbio.com|
|Melbourne, Victoria, Australia, 3004|
|Contact: Principal Investigator|