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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04575311




Registration number
NCT04575311
Ethics application status
Date submitted
29/09/2020
Date registered
5/10/2020
Date last updated
24/05/2024

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 will be random.

Placebo Comparator: Placebo: Dose Escalation - Participants will receive matching placebo as a single oral dose. Assignment to receive 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
AB680 Peak Plasma Concentration (Cmax)
Timepoint [1] 0 0
Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680
Primary outcome [2] 0 0
AB680 Time of Peak Concentration (Tmax)
Timepoint [2] 0 0
Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680
Primary outcome [3] 0 0
Area under the plasma concentration-time curve from time zero to t hours (AUC 0-t) of AB680
Timepoint [3] 0 0
Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680
Secondary outcome [1] 0 0
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
From First Dose Date to 15 Days After the Last Dose of AB680

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/09/2021
Sample size
Target
Accrual to date
Final
32
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/ct2/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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries