A Study to Investigate the Safety of AB680 in Healthy Volunteers

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03677973
• Other study ID #: AB680CSP0001
• Status: Completed
• Phase: Phase 1
• Start date: October 16, 2018
• Est. completion date: August 19, 2019

Study information

• Verified date: May 2024
• Source: Arcus Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 19, 2019
• Est. primary completion date: August 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• AB680
AB680 is a Cluster of Differentiation (CD)73 Inhibitor

Other:
• Placebo
Matching Placebo

Locations

Country	Name	City	State
Australia	Melbourne, VIC	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Arcus Biosciences, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Treatment Emergent Adverse Events (TEAEs).	Number of Participants with TEAEs as Assessed by CTCAE v5.0.	From First Dose Date to 15 Days After the Last Dose of AB680.
Primary	AB680 Peak Plasma Concentration (Cmax)	Cmax as Measured by the Area Under Concentration-Time Curve from Plasma Collection and Analysis.	From First Dose Date to 15 Days After the Last Dose of AB680.
Primary	AB680 Time of Peak Concentration (Tmax)	Tmax as Measured by the Time to Maximum Concentration-Time Curve from Plasma Collection and Analysis.	From First Dose Date to 15 Days After the Last Dose of AB680.
Secondary	Pharmacodynamic (PD) Effects of AB680	Enzymatic Activity of CD73 Measured in Participant Blood Samples.	From First Dose Date to 15 Days After the Last Dose of AB680.
Secondary	Plasma Levels of Adenosine	Amount of Adenosine Measured in Participant Blood Samples.	From First Dose Date to 15 Days After the Last Dose of AB680.

External Links

•   AB680CSP0001 - Lay Summary (English Version)