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The purpose of this study is to assess the pharmacokinetics (PK), bioavailability, immunogenicity, safety, and tolerability of ABBV-8736 following subcutaneous (SC) administration relative to intravenous (IV) administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Intravenous (IV) ABBV-8736 | Experimental | Participants will receive IV ABBV-8736 on Day 1. |
|
| Arm 2: Subcutaneous (SC) ABBV-8736 | Experimental | Participants will receive SC ABBV-8736 on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-8736 | Drug | Intravenous Injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Up to At Least 3 Months |
| Maximum Observed Serum Concentration (Cmax) of ABBV-8736 | Cmax of ABBV-8736. | Up to At Least 3 Months |
| Time to Maximum Observed Serum Concentration (Tmax) of ABBV-8736 | Tmax of ABBV-8736. | Up to At Least 3 Months |
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time Last (AUClast) of ABBV-8736 | AUClast of ABBV-8736. | Up to At Least 3 Months |
| AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-8736 | AUCinf of ABBV-8736. | Up to At Least 3 Months |
| Terminal Phase Elimination Rate Constant (β) of ABBV-8736 | β of ABBV-8736. | Up to At Least 3 Months |
| Terminal Elimination Half-Life (t1/2) of ABBV-8736 | t1/2 of ABBV-8736. | Up to At Least 3 Months |
| Apparent Clearance of the Analyte in Serum (CL) of ABBV-8736 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CenExel ACT- Anaheim Clinical Trials /ID# 280481 | Anaheim | California | 92801 | United States | ||
| Acpru /Id# 280382 |
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| ABBV-8736 |
| Drug |
Subcutaneous Injection |
|
CL of ABBV-8736. |
| Up to At Least 3 Months |
| Grayslake |
| Illinois |
| 60030 |
| United States |