Healthy Volunteers
Conditions
Brief summary
A Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Investigate the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers.
Detailed description
The study will evaluate minimum of 2 dose levels of AB680 in 8 participants per cohort. Cohorts will be gender-balanced to the extent possible, and will be randomized 3:1, active vs placebo, respectively. The participants will be closely observed for the first 48 hours following drug administration to monitor the general tolerability of AB680.
Interventions
DRUGAB680
AB680 is a Cluster of Differentiation (CD)73 Inhibitor
OTHERPlacebo
Matching Placebo
Sponsors
Arcus Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female participants aged 18 to 55 years, inclusive, at screening * Body mass index 18 to 32 kilograms/m\^2 inclusive * Willing and able to sign informed consent * Negative tests for hepatitis B surface antigen, anti-hepatitis C virus, and human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening * Healthy as determined by pre-study screening
Exclusion criteria
* History of clinically significant drug and/or food allergies * Positive drug and alcohol screen at screening and (each) admission to the clinical research center. * Participation in a drug study within 60 days prior to (the first) drug administration in the current study. Participation in more than 4 other drug studies in the 12 months prior to (the first) drug administration in the current study * Participants who have significant infection or known inflammatory process on screening or admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AB680 Peak Plasma Concentration (Cmax) | Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680 | Cmax as measured by the Area Under Concentration-Time Curve from Plasma Collection and Analysis. |
| AB680 Time of Peak Concentration (Tmax) | Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680 | Tmax as measured by the Time to Maximum Concentration-Time Curve from Plasma Collection and Analysis |
| Area under the plasma concentration-time curve from time zero to t hours (AUC 0-t) of AB680 | Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Treatment Emergent Adverse Events (TEAEs) | From First Dose Date to 15 Days After the Last Dose of AB680 | Number of participants with TEAEs as assessed by CTCAE v5.0. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamic (PD) Effects of AB680 | Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680] | Enzymatic Activity of CD73 measured in participant blood samples. |
Countries
Australia
Outcome results
None listed