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The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity after single ascending doses (SAD) of ABBV-141 in healthy adult Western and Asian participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1, ABBV-141 (Intravenous [IV]) | Experimental | Western participants will receive a single IV dose of ABBV-141. |
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| Part 1, Placebo for ABBV-141 (IV) | Placebo Comparator | Western participants will receive a single IV dose of placebo for ABBV-141. |
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| Part 1, ABBV-141 (subcutaneous [SC]) | Experimental | Western participants will receive a single SC dose of ABBV-141. |
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| Part 1, Placebo for ABBV-141 (SC) | Placebo Comparator | Western participants will receive a single SC dose of placebo for ABBV-141. |
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| Part 2, ABBV-141 (IV) | Experimental | Asian participants will receive a single IV dose of ABBV-141. |
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| Part 2, Placebo for ABBV-141 (IV) | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-141 | Drug | Infusion; intravenous (IV) |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of ABBV-141 | Cmax of ABBV-141 will be assessed. | Up to Day 85 |
| Time to Cmax (Tmax) of ABBV-141 | Tmax of ABBV-141 will be assessed. | Up to Day 85 |
| Area Under the Serum Concentration-time Curve (AUC) of ABBV-141 from time 0 to the time of last measurable concentration (AUCt) | AUCt of ABBV-141 will be determined. | Up to Day 85 |
| AUC of ABBV-141 from Time 0 to Infinity (AUCinf) | AUCinf of ABBV-141 will be assessed. | Up to Day 85 |
| Terminal Phase Elimination Rate Constant (β) of ABBV-141 | Terminal phase elimination rate constant (β) of ABBV-141 will be assessed. | Up to Day 85 |
| Terminal Phase Elimination Half-life (t1/2) of ABBV-141 | Terminal phase elimination half-life (t1/2) of ABBV-141 will be assessed. | Up to Day 85 |
| Dose Normalized Cmax of ABBV-141 | Dose normalized Cmax of ABBV-141 will be assessed. | Up to Day 85 |
| Dose Normalized AUC of ABBV-141 | Dose normalized AUC of ABBV-141 will be assessed. |
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Inclusion Criteria:
For Part 2 only:
-Han Chinese ethnicity or Japanese ethnicity based on the following criteria:
Exclusion Criteria:
Additionally for Part 1, only:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acpru /Id# 261162 | Grayslake | Illinois | 60030 | United States |
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Asian participants will receive a single IV dose of placebo for ABBV-141.
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| Part 2, ABBV-141 (SC) | Experimental | Asian participants will receive a single SC dose of ABBV-141. |
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| Part 2, Placebo for ABBV-141 (SC) | Placebo Comparator | Asian participants will receive a single SC dose of placebo for ABBV-141. |
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| Placebo for ABBV-141 | Drug | Infusion; IV |
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| ABBV-141 | Drug | Injection; subcutaneous (SC) |
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| Placebo for ABBV-141 | Drug | Injection; SC |
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| Up to Day 85 |
| Number of Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Baseline to Day 85 |