A Study to Investigate the Safety of AB680 in Healthy Volunteers

NCT03677973 | Completed Phase 1

• 1 other identifier: AB680CSP0001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (2)

• Pharmacodynamic (PD) Effects of AB680

  From First Dose Date to 15 Days After the Last Dose of AB680.

• Plasma Levels of Adenosine

  From First Dose Date to 15 Days After the Last Dose of AB680.

Study Arms (2)

Active: Dose Escalation

ACTIVE COMPARATOR

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

Placebo: Dose Escalation

PLACEBO COMPARATOR

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

Interventions

AB680 DRUG

AB680 is a Cluster of Differentiation (CD)73 Inhibitor

Active: Dose Escalation

Placebo OTHER

Matching Placebo

Placebo: Dose Escalation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arcus Biosciences, Inc.: lead

Study Sites (1)

Melbourne, VIC

Melbourne, Victoria, 3004, Australia

Location

Related Publications (1)

• 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.

  PMID: 31334635 DERIVED

Related Links

• AB680CSP0001 - Lay Summary (English Version)

MeSH Terms

Interventions

quemliclustat

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 19, 2018
• Study Start: October 16, 2018
• Primary Completion: August 19, 2019
• Study Completion: August 19, 2019
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

AU (1)