A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AB801 in Healthy Volunteers (ARC-26)

February 16, 2024 updated by: Arcus Biosciences, Inc.

A Phase 1, Double-Blinded, Randomised, Placebo-Controlled, Single Ascending Dose (SAD) Study in Healthy Subjects to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of AB801

The primary purpose of this study is to determine the safety and tolerability of AB801, and to understand the pharmacokinetic (PK) profile of AB801 when taken as a capsule and tablet in healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom
        • Quotient Sciences - Nottingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Key Inclusion Criteria:

  • Healthy as determined by medical evaluation by study physician
  • Body mass index (BMI) of 18.0 to 32.0 kilogram (kg)/meter (m)^2 as measured at screening
  • Weight ≥ 50 kg at screening
  • Must agree to adhere to the protocol defined contraception requirements

Key Exclusion Criteria:

  • Do not have suitable veins for multiple venepunctures/cannulation as assessed by the study physician
  • Prolonged QT interval defined as mean Corrected QT interval by Fridericia's formula (QTcF) ≥ 450 msec for males and > 470 millisecond (msec) for females at screening and pre-dose
  • Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the study physician
  • Received any study medicine in a clinical research study within the last 90 days
  • Taking, or have taken, any prescribed or over-the-counter drugs including gastric acid reducing agents and including CYP3A inhibitor and/or inducers

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 - AB801 Dose A
Participants will receive a single dose of AB801 or placebo
Drug: Placebo
Administered as specified in the treatment arm
Drug: AB801
Administered as specified in the treatment arm
Experimental: Cohort 2 - AB801 Dose B
Participants will receive a single dose of AB801 or placebo
Drug: Placebo
Administered as specified in the treatment arm
Drug: AB801
Administered as specified in the treatment arm
Experimental: Cohort 3 - AB801 Dose C
Participants will receive a single dose of AB801 or placebo
Drug: Placebo
Administered as specified in the treatment arm
Drug: AB801
Administered as specified in the treatment arm
Experimental: Cohort 4 - AB801 Dose D
Participants will receive a single dose of AB801 or placebo
Drug: Placebo
Administered as specified in the treatment arm
Drug: AB801
Administered as specified in the treatment arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events (AEs)
Time Frame: Up to 30 days
Up to 30 days
Area Under the Plasma Drug Concentration-Time Curve (AUC)
Time Frame: Predose, Up to 120 hours postdose
Predose, Up to 120 hours postdose
Maximum Concentration (Cmax) in Plasma
Time Frame: Predose, Up to 120 hours postdose
Predose, Up to 120 hours postdose
Time to Maximum Concentration (Tmax) in Plasma
Time Frame: Predose, Up to 120 hours postdose
Predose, Up to 120 hours postdose
Half-Life Time (t1/2)
Time Frame: Predose, Up to 120 hours postdose
Predose, Up to 120 hours postdose

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Holter Electrocardiogram Monitoring Scale
Time Frame: Predose up to 25 hours postdose
Predose up to 25 hours postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arcus Biosciences, Inc.

Investigators

  • Study Director: Medical Director, Arcus Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2023

Primary Completion (Actual)

February 15, 2024

Study Completion (Actual)

February 15, 2024

Study Registration Dates

First Submitted

August 15, 2023

First Submitted That Met QC Criteria

August 15, 2023

First Posted (Actual)

August 22, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ARC-26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

For more information, please visit our website.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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