Healthy VolunteersPhase 1NCT04575311
A Study to Investigate the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers
A Phase 1 study testing AB680 in people with Healthy Volunteers, run by Arcus Biosciences, Inc. at 1 site in Australia.
Trial summary
A Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Investigate the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AB680
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 20 Oct 2020to 22 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Investigate the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers
A Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Investigate the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- AB680, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB680Drug
AB680 is a Cluster of Differentiation (CD)73 Inhibitor
PlaceboOther
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active: Dose Escalation | Active comparator | Participants will receive a single oral dose of AB680 at one of two ascending dose levels. Assignment to receive AB680 will be random. Receives: Drug: AB680 |
| Placebo: Dose Escalation | Placebo comparator | Participants will receive matching placebo as a single oral dose. Assignment to receive matching placebo will be random. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AB680 Peak Plasma Concentration (Cmax)
Cmax as measured by the Area Under Concentration-Time Curve from Plasma Collection and Analysis.
Measured: Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680
AB680 Time of Peak Concentration (Tmax)
Tmax as measured by the Time to Maximum Concentration-Time Curve from Plasma Collection and Analysis
Measured: Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680
Area under the plasma concentration-time curve from time zero to t hours (AUC 0-t) of AB680
Measured: Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680
Secondary outcomes (1)
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Number of participants with TEAEs as assessed by CTCAE v5.0.
Measured: From First Dose Date to 15 Days After the Last Dose of AB680
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start20 Oct 2020
- Primary completion22 Sep 2021
- Study completion22 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arcus Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575311
- Sponsor's protocol ID
- ARC-11
- Status last verified
- May 2024
- First submitted
- 29 Sep 2020
- Last updated
- 24 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Investigate the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04575311
- Acronym / sponsor ID
- ARC-11
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Arcus Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 22 Sep 2021 (actual)
- Study completion
- 22 Sep 2021 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active: Dose Escalation | Active comparator | Drug: AB680Participants will receive a single oral dose of AB680 at one of two ascending dose levels. Assignment to receive AB680 will be random. |
| Placebo: Dose Escalation | Placebo comparator | Other: PlaceboParticipants will receive matching placebo as a single oral dose. Assignment to receive matching placebo will be random. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AB680AB680 is a Cluster of Differentiation (CD)73 Inhibitor | Drug | Active: Dose Escalation |
| PlaceboMatching Placebo | Other | Placebo: Dose Escalation |
Primary outcome
AB680 Peak Plasma Concentration (Cmax)
Time frame: 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)
Time frame: 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
Time frame: Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680
1 secondary outcome
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: From First Dose Date to 15 Days After the Last Dose of AB680
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- ARC-11 - Lay Summary (English Version)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AB680 in people with Healthy Volunteers, run by Arcus Biosciences, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AB680 Peak Plasma Concentration (Cmax) (time frame: Pre-dose; from First Dose Date to 15 Days After the Last Dose of AB680). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.