CancerPhase 1ARC-26NCT06004921
A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AB801 in Healthy Volunteers
A Phase 1 study testing AB801 in people with Cancer, run by Arcus Biosciences, Inc. at 1 site in United Kingdom.
Trial summary
The primary purpose of this study is to determine the safety and tolerability of AB801, and to understand the pharmacokinetic (PK) profile of AB801 when taken as a capsule and tablet 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
- Cancer
- What is being tested?
- AB801
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Oct 2023to 23 Feb 2024
- 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
- Healthy as determined by medical evaluation by study physician
- Body mass index (BMI) of 18.0 to 32.0 kilogram (kg)/meter (m)^2 as measured at screening
- Weight ≥ 50 kg at screening
- Must agree to adhere to the protocol defined contraception requirements
Who cannot join
- Do not have suitable veins for multiple venepunctures/cannulation as assessed by the study physician
- Prolonged QT interval defined as mean Corrected QT interval by Fridericia's formula (QTcF) ≥ 450 msec for males and > 470 millisecond (msec) for females at screening and pre-dose
- Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the study physician
- Received any study medicine in a clinical research study within the last 90 days
- Taking, or have taken, any prescribed or over-the-counter drugs including gastric acid reducing agents and including CYP3A inhibitor and/or inducers
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-Blinded, Randomised, Placebo-Controlled, Single Ascending Dose (SAD) Study in Healthy Subjects to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of AB801
The primary purpose of this study is to determine the safety and tolerability of AB801, and to understand the pharmacokinetic (PK) profile of AB801 when taken as a capsule and tablet in healthy volunteers.
- Conditions
- Cancer
- Being tested
- AB801, Placebo
- Keywords
- AB801, Healthy volunteer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB801Drug
Administered as specified in the treatment arm
PlaceboDrug
Administered as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - AB801 Dose A | Experimental | Participants will receive a single dose of AB801 or placebo Receives: Drug: AB801; Drug: Placebo |
| Cohort 2 - AB801 Dose B | Experimental | Participants will receive a single dose of AB801 or placebo Receives: Drug: AB801; Drug: Placebo |
| Cohort 3 - AB801 Dose C | Experimental | Participants will receive a single dose of AB801 or placebo Receives: Drug: AB801; Drug: Placebo |
| Cohort 4 - AB801 Dose D | Experimental | Participants will receive a single dose of AB801 or placebo Receives: Drug: AB801; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
Measured: Up to 30 days
Area Under the Plasma Drug Concentration-Time Curve (AUC)
Measured: Predose, Up to 120 hours postdose
Maximum Concentration (Cmax) in Plasma
Measured: Predose, Up to 120 hours postdose
Time to Maximum Concentration (Tmax) in Plasma
Measured: Predose, Up to 120 hours postdose
Half-Life Time (t1/2)
Measured: Predose, Up to 120 hours postdose
Secondary outcomes (1)
Change from Baseline in Holter Electrocardiogram Monitoring Scale
Measured: Predose up to 25 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start16 Oct 2023
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Investigators
- Medical Director, Study director, Arcus Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004921
- Sponsor's protocol ID
- ARC-26
- Acronym
- ARC-26
- Status last verified
- May 2024
- First submitted
- 15 Aug 2023
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blinded, Randomised, Placebo-Controlled, Single Ascending Dose (SAD) Study in Healthy Subjects to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of AB801
- ClinicalTrials.gov ID
- NCT06004921
- Acronym / sponsor ID
- ARC-26 / ARC-26
- Conditions
- Cancer
- Keywords
- AB801, Healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Arcus Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 22 Aug 2023 (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.
The primary purpose of this study is to determine the safety and tolerability of AB801, and to understand the pharmacokinetic (PK) profile of AB801 when taken as a capsule and tablet in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - AB801 Dose A | Experimental | Drug: AB801, Drug: PlaceboParticipants will receive a single dose of AB801 or placebo |
| Cohort 2 - AB801 Dose B | Experimental | Drug: AB801, Drug: PlaceboParticipants will receive a single dose of AB801 or placebo |
| Cohort 3 - AB801 Dose C | Experimental | Drug: AB801, Drug: PlaceboParticipants will receive a single dose of AB801 or placebo |
| Cohort 4 - AB801 Dose D | Experimental | Drug: AB801, Drug: PlaceboParticipants will receive a single dose of AB801 or placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy as determined by medical evaluation by study physician
- Body mass index (BMI) of 18.0 to 32.0 kilogram (kg)/meter (m)^2 as measured at screening
- Weight ≥ 50 kg at screening
- Must agree to adhere to the protocol defined contraception requirements
Key exclusion criteria (6 listed)
- Do not have suitable veins for multiple venepunctures/cannulation as assessed by the study physician
- Prolonged QT interval defined as mean Corrected QT interval by Fridericia's formula (QTcF) ≥ 450 msec for males and > 470 millisecond (msec) for females at screening and pre-dose
- Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the study physician
- Received any study medicine in a clinical research study within the last 90 days
- Taking, or have taken, any prescribed or over-the-counter drugs including gastric acid reducing agents and including CYP3A inhibitor and/or inducers
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 |
|---|---|---|
| AB801Administered as specified in the treatment arm | Drug | Cohort 1 - AB801 Dose A, Cohort 2 - AB801 Dose B, Cohort 3 - AB801 Dose C, Cohort 4 - AB801 Dose D |
| PlaceboAdministered as specified in the treatment arm | Drug | Cohort 1 - AB801 Dose A, Cohort 2 - AB801 Dose B, Cohort 3 - AB801 Dose C, Cohort 4 - AB801 Dose D |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to 30 days
Area Under the Plasma Drug Concentration-Time Curve (AUC)
Time frame: Predose, Up to 120 hours postdose
Maximum Concentration (Cmax) in Plasma
Time frame: Predose, Up to 120 hours postdose
Time to Maximum Concentration (Tmax) in Plasma
Time frame: Predose, Up to 120 hours postdose
Half-Life Time (t1/2)
Time frame: Predose, Up to 120 hours postdose
1 secondary outcome
Change from Baseline in Holter Electrocardiogram Monitoring Scale
Time frame: Predose up to 25 hours postdose
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 28 Aug 2024.
- 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.
Medical Director study director
Arcus Biosciences
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 AB801 in people with Cancer, run by Arcus Biosciences, Inc. at 1 site in United Kingdom.
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 4 inclusion and 6 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 28 Aug 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 United Kingdom. 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. 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 Adverse Events (AEs) (time frame: Up to 30 days). The study lists 5 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 28 Aug 2024.