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

Arcus Biosciences

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: Placebo; Drug: AB801

Study type: Interventional

Funder types: Industry

Identifiers

NCT06004921

ARC-26

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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32 participants in 4 patient groups

Cohort 1 - AB801 Dose A

Experimental group

Description:

Participants will receive a single dose of AB801 or placebo

Treatment:

Drug: AB801

Drug: Placebo

Cohort 2 - AB801 Dose B

Experimental group

Description:

Participants will receive a single dose of AB801 or placebo

Treatment:

Drug: AB801

Drug: Placebo

Cohort 3 - AB801 Dose C

Experimental group

Description:

Participants will receive a single dose of AB801 or placebo

Treatment:

Drug: AB801

Drug: Placebo

Cohort 4 - AB801 Dose D

Experimental group

Description:

Participants will receive a single dose of AB801 or placebo

Treatment:

Drug: AB801

Drug: Placebo