Healthy VolunteersPhase 1NCT03677973
A Study to Investigate the Safety of 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
This is 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. 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
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteAustralia
- Study dates
- 16 Oct 2018to 19 Aug 2019
- 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
- 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
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- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB680 in Healthy Volunteers
This is 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.
Read the detailed description
AB680 will be administered as single and multiple intravenous doses to the healthy volunteers. In each group of 8 participants, 6 will receive AB680 and 2 will receive matching placebo.
The participants will be closely observed 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 | 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. Receives: Drug: AB680 |
| Placebo: Dose Escalation | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
AB680 Peak Plasma Concentration (Cmax)
Cmax as Measured by the Area Under Concentration-Time Curve from Plasma Collection and Analysis.
Measured: 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: From First Dose Date to 15 Days After the Last Dose of AB680.
Secondary outcomes (2)
Pharmacodynamic (PD) Effects of AB680
Enzymatic Activity of CD73 Measured in Participant Blood Samples.
Measured: From First Dose Date to 15 Days After the Last Dose of AB680.
Plasma Levels of Adenosine
Amount of Adenosine Measured in Participant Blood Samples.
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 posted19 Sep 2018
- Study start16 Oct 2018
- Primary completion19 Aug 2019
- Study completion19 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 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
- NCT03677973
- Sponsor's protocol ID
- AB680CSP0001
- Status last verified
- May 2024
- First submitted
- 18 Sep 2018
- 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.
Publications
Bowman CE, da Silva RG, Pham A, Young SW. An Exceptionally Potent Inhibitor of Human CD73. Biochemistry. 2019 Aug 6;58(31):3331-3334. doi: 10.1021/acs.biochem.9b00448. Epub 2019 Jul 23.
PubMed 31334635
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- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB680 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03677973
- Acronym / sponsor ID
- AB680CSP0001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Arcus Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 19 Aug 2019 (actual)
- Study completion
- 19 Aug 2019 (actual)
- First posted
- 19 Sep 2018 (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.
This is 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.
Detailed description
AB680 will be administered as single and multiple intravenous doses to the healthy volunteers. In each group of 8 participants, 6 will receive AB680 and 2 will receive matching placebo.
The participants will be closely observed to monitor the general tolerability of AB680.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active: Dose Escalation | Active comparator | Drug: AB680Healthy 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: Dose Escalation | Placebo comparator | Other: PlaceboHealthy 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
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
Number of Participants with Treatment Emergent Adverse Events (TEAEs).
Time frame: From First Dose Date to 15 Days After the Last Dose of AB680.
Number of Participants with TEAEs as Assessed by CTCAE v5.0.
AB680 Peak Plasma Concentration (Cmax)
Time frame: 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: 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.
2 secondary outcomes
Pharmacodynamic (PD) Effects of AB680
Time frame: From First Dose Date to 15 Days After the Last Dose of AB680.
Plasma Levels of Adenosine
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.
- Derived from this study: PubMed 31334635Bowman CE, da Silva RG, Pham A, Young SW. An Exceptionally Potent Inhibitor of Human CD73. Biochemistry. 2019 Aug 6;58(31):3331-3334. doi: 10.1021/acs.biochem.9b00448. Epub 2019 Jul 23.
- AB680CSP0001 - 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?
Number of Participants with Treatment Emergent Adverse Events (TEAEs). (time frame: 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?
On the ClinicalTrials.gov record for NCT03677973, which also lists 1 linked publication.
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.