A Study to Investigate the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers

NCT04575311 | Completed Phase 1

• 1 other identifier: ARC-11
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

A Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Investigate the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• AB680 Peak Plasma Concentration (Cmax)

  Cmax as measured by the Area Under Concentration-Time Curve from Plasma Collection and Analysis.

  Pre-dose; 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

  Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680

• Area under the plasma concentration-time curve from time zero to t hours (AUC 0-t) of AB680

  Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680

Secondary Outcomes (1)

• Number of participants with Treatment Emergent Adverse Events (TEAEs)

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

Other Outcomes (1)

• Pharmacodynamic (PD) Effects of AB680

  Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680]

Study Arms (2)

Active: Dose Escalation

ACTIVE COMPARATOR

Participants will receive a single oral dose of AB680 at one of two ascending dose levels. Assignment to receive AB680 will be random.

Drug: AB680

Placebo: Dose Escalation

PLACEBO COMPARATOR

Participants will receive matching placebo as a single oral dose. Assignment to receive 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:

• Male or female participants aged 18 to 55 years, inclusive, at screening
• Body mass index 18 to 32 kilograms/m\^2 inclusive
• 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)

Nucleus Network

Melbourne, Victoria, Australia

Location

Related Links

• ARC-11 - Lay Summary (English Version)

MeSH Terms

Interventions

quemliclustat

Study Design

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

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 5, 2020
• Study Start: October 20, 2020
• Primary Completion: September 22, 2021
• Study Completion: September 22, 2021
• 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)