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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03677973




Registration number
NCT03677973
Ethics application status
Date submitted
18/09/2018
Date registered
19/09/2018

Titles & IDs
Public title
A Study to Investigate the Safety of AB680 in Healthy Volunteers
Scientific title
A Double-Blind, Randomized, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB680 in Healthy Volunteers
Secondary ID [1] 0 0
AB680CSP0001
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 - Healthy volunteers will receive AB680 as a single intravenous (IV) infusion at 7 dose levels and as multiple IV infusions at 1 dose level. Assignment to receive AB680 or matching placebo will be random.

Placebo comparator: Placebo: Dose Escalation - Healthy volunteers will receive matching placebo as a single IV infusion and as multiple IV infusions. 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).
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)
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)
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
Timepoint [1] 0 0
From First Dose Date to 15 Days After the Last Dose of AB680.
Secondary outcome [2] 0 0
Plasma Levels of Adenosine
Timepoint [2] 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 18 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
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 administering the treatment/s
The people assessing the outcomes
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
16/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/08/2019
Sample size
Target
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Melbourne, VIC - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

For more information, please visit our website.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://trials.arcusbio.com/our-transparency-policy


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03677973