A Single Ascending Dose (SAD) Study of AB801 in Healthy Subjects (QSC207788)
Research type
Research Study
Full 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
IRAS ID
1007792
Contact name
Lawrence Lu
Contact email
Sponsor organisation
Arcus Biosciences, Inc.
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the test medicine, AB801, for the potential treatment of cancer, when combined with other anti-cancer therapies such as chemotherapy (known as a combination agent). Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably. The cancerous cells can invade and destroy surrounding healthy tissue, including organs.
This single-part, first-in-human healthy volunteer study will try to identify the safety and tolerability of the test medicine, as well as the pharmacokinetics (PK – what the body does to the drug) when given as single ascending doses.
This study will take place at one non-NHS site, enrolling up to 32 male and female (of non-childbearing potential) volunteers, aged between 18-55 years, inclusive.
Volunteers will be split into 4 groups. Each group will receive a single dose of the test medicine or placebo [6:2 AB801:placebo], at different dose levels, in the fasted state. The planned starting dose is 10 mg. Two volunteers per group [1:1 AB801:placebo] will be dosed ahead of the full group (sentinel dosing) to assess if the dose level is safe. The first two groups will receive the test medicine in the form of a capsule and, a tablet formulation (recipe) may be utilised from group 3 onwards. The dose given to volunteers in later groups may be higher than previously given pending review of PK and safety data. Volunteers will be discharged on Day 6 and will return to the clinical unit for a follow-up visit between Days 8 to 12. Additional groups may be added if deemed to be required after review of the PK and safety data of the previous 4 groups.
Volunteer’s blood and urine will be taken throughout the study for analysis of the test medicine and for their safety.
Volunteers are expected to be involved in this study for approximately 6 weeks from screening to the follow-up visit.
REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0505
Date of REC Opinion
9 Oct 2023
REC opinion
Further Information Favourable Opinion