A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AB801 in Healthy Volunteers
- Registration Number
- NCT06004921
- Lead Sponsor
- Arcus Biosciences, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 4 - AB801 Dose D AB801 Participants will receive a single dose of AB801 or placebo Cohort 4 - AB801 Dose D Placebo Participants will receive a single dose of AB801 or placebo Cohort 1 - AB801 Dose A AB801 Participants will receive a single dose of AB801 or placebo Cohort 1 - AB801 Dose A Placebo Participants will receive a single dose of AB801 or placebo Cohort 2 - AB801 Dose B AB801 Participants will receive a single dose of AB801 or placebo Cohort 2 - AB801 Dose B Placebo Participants will receive a single dose of AB801 or placebo Cohort 3 - AB801 Dose C AB801 Participants will receive a single dose of AB801 or placebo Cohort 3 - AB801 Dose C Placebo Participants will receive a single dose of AB801 or placebo
- Primary Outcome Measures
Name Time Method 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 Half-Life Time (t1/2) Predose, Up to 120 hours postdose Time to Maximum Concentration (Tmax) in Plasma Predose, Up to 120 hours postdose
- Secondary Outcome Measures
Name Time Method Change from Baseline in Holter Electrocardiogram Monitoring Scale Predose up to 25 hours postdose
Trial Locations
- Locations (1)
Quotient Sciences - Nottingham
🇬🇧Nottingham, United Kingdom