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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04575311




Registration number
NCT04575311
Ethics application status
Date submitted
29/09/2020
Date registered
5/10/2020
Date last updated
24/02/2021

Titles & IDs
Public title
A Study to Investigate the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers
Scientific title
A Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Investigate the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers
Secondary ID [1] 0 0
ARC-11
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AB680
Other interventions - Placebo

Active Comparator: Active: Dose Escalation - Participants will receive a single oral dose of AB680 at one of two ascending dose levels. Assignment to receive AB680 or matching placebo will be random.

Placebo Comparator: Placebo: Dose Escalation - Participants will receive matching placebo as a single oral dose. Assignment to receive AB680 or matching placebo will be random.


Treatment: Drugs: AB680
AB680 is a Cluster of Differentiation (CD)73 Inhibitor

Other interventions: Placebo
Matching Placebo

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Treatment Emergent Adverse Events (TEAEs) - Number of Participants with TEAEs as Assessed by CTCAE v5.0.
Timepoint [1] 0 0
From First Dose Date to 15 Days After the Last Dose of AB680
Primary outcome [2] 0 0
AB680 Peak Plasma Concentration (Cmax) - Cmax as Measured by the Area Under Concentration-Time Curve from Plasma Collection and Analysis.
Timepoint [2] 0 0
From First Dose Date to 15 Days After the Last Dose of AB680
Primary outcome [3] 0 0
AB680 Time of Peak Concentration (Tmax) - Tmax as Measured by the Time to Maximum Concentration-Time Curve from Plasma Collection and Analysis
Timepoint [3] 0 0
From First Dose Date to 15 Days After the Last Dose of AB680
Secondary outcome [1] 0 0
Pharmacodynamic (PD) Effects of AB680 - Enzymatic Activity of CD73 Measured in Participant Blood Samples.
Timepoint [1] 0 0
From First Dose Date to 15 Days After the Last Dose of AB680

Eligibility
Key inclusion criteria
- 18 to 55 years, inclusive, at screening

- Body mass index 19 to 30 kg/m2

- 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
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Arcus Biosciences, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Investigate
the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers.
Trial website
https://clinicaltrials.gov/show/NCT04575311
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Medical Monitor
Address 0 0
Country 0 0
Phone 0 0
510-694-6200
Fax 0 0
Email 0 0
ClinicalTrialInquiry@arcusbio.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04575311