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

NCT06004921 | Completed Phase 1 FDA Drug

• 1 other identifier: ARC-26
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

AB801; Healthy volunteer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Change from Baseline in Holter Electrocardiogram Monitoring Scale

  Predose up to 25 hours postdose

Study Arms (4)

Cohort 1 - AB801 Dose A

EXPERIMENTAL

Participants will receive a single dose of AB801 or placebo

Drug: AB801; Drug: Placebo

Cohort 2 - AB801 Dose B

EXPERIMENTAL

Participants will receive a single dose of AB801 or placebo

Drug: AB801; Drug: Placebo

Cohort 3 - AB801 Dose C

EXPERIMENTAL

Participants will receive a single dose of AB801 or placebo

Drug: AB801; Drug: Placebo

Cohort 4 - AB801 Dose D

EXPERIMENTAL

Participants will receive a single dose of AB801 or placebo

Drug: AB801; Drug: Placebo

Interventions

AB801 DRUG

Administered as specified in the treatment arm

Cohort 1 - AB801 Dose A; Cohort 2 - AB801 Dose B; Cohort 3 - AB801 Dose C; Cohort 4 - AB801 Dose D

Placebo DRUG

Administered as specified in the treatment arm

Cohort 1 - AB801 Dose A; Cohort 2 - AB801 Dose B; Cohort 3 - AB801 Dose C; Cohort 4 - AB801 Dose D

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arcus Biosciences, Inc.: lead

Study Sites (1)

Quotient Sciences - Nottingham

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Medical Director

  Arcus Biosciences

  STUDY DIRECTOR

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: August 15, 2023
• First Posted: August 22, 2023
• Study Start: October 16, 2023
• Primary Completion: February 23, 2024
• Study Completion: February 23, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

GB (1)