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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-526279-52-00 | EU Trial (CTIS) Number |
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The purpose of this study is assess the safety and tolerability of AB102 and characterize the pharmacokinetics (PK) profile of AB102 after single and multiple ascending oral dose(s).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD Part | Experimental | Escalating single oral doses of AB102 will be given to participants |
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| SAD Part Placebo | Experimental | Escalating single oral doses of placebo will be given to participants |
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| MAD Part | Placebo Comparator | Escalating multiple oral doses of AB102 will be given to participants |
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| MAD Part Placebo | Placebo Comparator | Escalating multiple oral doses of placebo will be given to participants |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AB102 | Drug | Administered orally as specified in the treatment arm |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing Adverse Events (AEs) | Up to 49 days | |
| Maximum observed plasma concentration (Cmax) for SAD and MAD Parts | Up to 28 days | |
| Time to attain maximum observed plasma concentration (tmax) for SAD and MAD Parts | Up to 28 days | |
| Terminal elimination half-life (t1/2) for SAD Part | Up to 28 days | |
| Area under the plasma concentration-time curve from time 0 to last sample (AUClast) for SAD and MAD Parts | Up to 28 days | |
| Area under the plasma concentration-time curve from time 0 to 24 hours (AUC0-24h) for SAD Part | Up to 28 days | |
| Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) for SAD Part | Up to 28 days | |
| Area under the plasma concentration-time curve over a dosing interval (AUC0-tau) for MAD Part | Up to 28 days | |
| Accumulation ratio (Racc(Cmax))for MAD Part | Up to 28 days | |
| Accumulation ratio(Racc(AUCtau)) for MAD Part | Up to 28 days |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Contact | +1-510-462-3330 | ClinicalTrialInquiry@arcusbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Arcus Biosciences | Study Director |
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Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, SAP, CSR) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, visit: https://trials.arcusbio.com/our-transparency-policy
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| Placebo |
| Other |
Administered orally as specified in the treatment arm |
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