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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - AB801 Dose A | Experimental | Participants will receive a single dose of AB801 or placebo |
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| Cohort 2 - AB801 Dose B | Experimental | Participants will receive a single dose of AB801 or placebo |
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| Cohort 3 - AB801 Dose C | Experimental | Participants will receive a single dose of AB801 or placebo |
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| Cohort 4 - AB801 Dose D | Experimental | Participants will receive a single dose of AB801 or placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AB801 | Drug | Administered as specified in the treatment arm |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Up to 30 days | |
| Area Under the Plasma Drug Concentration-Time Curve (AUC) | Predose, Up to 120 hours postdose | |
| Maximum Concentration (Cmax) in Plasma | Predose, Up to 120 hours postdose | |
| Time to Maximum Concentration (Tmax) in Plasma | Predose, Up to 120 hours postdose | |
| Half-Life Time (t1/2) | Predose, Up to 120 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Holter Electrocardiogram Monitoring Scale | Predose up to 25 hours postdose |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Arcus Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences - Nottingham | Nottingham | United Kingdom |
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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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Placebo | Drug | Administered as specified in the treatment arm |
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