A Study to Investigate the Safety of AB680 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: AB680; Other: Placebo

• Registration Number: NCT03677973
• Lead Sponsor: Arcus Biosciences, Inc.

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 Timeline

• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-09-18
• Study First Posted: 2018-09-19
• Study Start: 2018-10-16
• Primary Completion: 2019-08-19
• Study Completion: 2019-08-19
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Active: Dose Escalation	AB680	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.
Placebo: Dose Escalation	Placebo	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.

Primary Outcome Measures

Name	Time	Method
AB680 Peak Plasma Concentration (Cmax)	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)	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.
Number of Participants with Treatment Emergent Adverse Events (TEAEs).	From First Dose Date to 15 Days After the Last Dose of AB680.	Number of Participants with TEAEs as Assessed by CTCAE v5.0.

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic (PD) Effects of AB680	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	From First Dose Date to 15 Days After the Last Dose of AB680.	Amount of Adenosine Measured in Participant Blood Samples.

Trial Locations

Locations (1)

Melbourne, VIC; 🇦🇺 Melbourne, Victoria, Australia