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OpenTrials
Completed

NCT Number: NCT06004921

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences - Nottingham

Nottingham, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AB801

Drug

Administered as specified in the treatment arm

Placebo

Drug

Administered as specified in the treatment arm

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to 30 days

  2. Area Under the Plasma Drug Concentration-Time Curve (AUC)

    Time frame: Predose, Up to 120 hours postdose

  3. Maximum Concentration (Cmax) in Plasma

    Time frame: Predose, Up to 120 hours postdose

  4. Time to Maximum Concentration (Tmax) in Plasma

    Time frame: Predose, Up to 120 hours postdose

  5. Half-Life Time (t1/2)

    Time frame: Predose, Up to 120 hours postdose

Secondary outcomes

  1. Change from Baseline in Holter Electrocardiogram Monitoring Scale

    Time frame: Predose up to 25 hours postdose

Sponsors and collaborators

Lead sponsor

Arcus Biosciences, Inc.

Industry

Registry information

Official study 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

Acronym: ARC-26

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2023
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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