A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AB801 in Healthy Volunteers

Sponsor

Arcus Biosciences, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06004921

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: AB801 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Change from Baseline in Holter Electrocardiogram Monitoring Scale [Predose up to 25 hours postdose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Arcus Biosciences, Inc.

Investigators

Study Director: Medical Director, Arcus Biosciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Arcus Biosciences, Inc.

ClinicalTrials.gov Identifier:

NCT06004921

Other Study ID Numbers:

ARC-26

First Posted:

Aug 22, 2023

Last Update Posted:

Aug 22, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Arcus Biosciences, Inc.

AB801

Healthy volunteer

Study Results

No Results Posted as of Aug 22, 2023