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

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: Cancer
• Intervention / Treatment: Drug: Placebo; Drug: AB801

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

4

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)	Up to 30 days
Area Under the Plasma Drug Concentration-Time Curve (AUC)	Predose, Up to 120 hours postdose
Maximum Concentration (Cmax) in Plasma	Predose, Up to 120 hours postdose
Time to Maximum Concentration (Tmax) in Plasma	Predose, Up to 120 hours postdose
Half-Life Time (t1/2)	Predose, Up to 120 hours postdose

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Arcus Biosciences, Inc.
• Investigators: Study Director: Medical Director, Arcus Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Actual): February 23, 2024
• Study Completion (Actual): February 23, 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): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Healthy volunteer; AB801
• 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