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The objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity following multiple intravenous (IV) ascending doses of ABBV-8736 in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Dose A of ABBV-8736 | Experimental | Participants will receive intravenous (IV) ABBV-8736 dose A every 2 weeks for a total of 3 doses. |
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| Group 1: Dose A of ABBV-8736 Placebo | Placebo Comparator | Participants will receive IV ABBV-8736 placebo dose A every 2 weeks for a total of 3 doses. |
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| Group 2: Dose B of ABBV-8736 | Experimental | Participants will receive IV ABBV-8736 dose B every 2 weeks for a total of 3 doses. |
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| Group 2: Dose B of ABBV-8736 Placebo | Placebo Comparator | Participants will receive IV ABBV-8736 placebo dose B every 2 weeks for a total of 3 doses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-8736 | Drug | Intravenous (IV) Infusion |
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| 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 Approximately 113 Days |
| Maximum Observed Concentration (Cmax) of ABBV-8736 | Cmax of ABBV-8736. | Up to Approximately 113 Days |
| Time to Cmax (Tmax) of ABBV-8736 | Tmax of ABBV-8736. | Up to Approximately 113 Days |
| Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of ABBV-8736 | AUCtau of ABBV-8736. | Up to Approximately 113 Days |
| Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-8736 | Ctrough of ABBV-8736. | Up to Approximately 113 Days |
| Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-8736 | β of ABBV-8736. | Up to Approximately 113 Days |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-8736 | t1/2 of ABBV-8736. | Up to Approximately 113 Days |
| Clearance (CL) for Intravenous (IV) Dosing |
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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 |
|---|---|---|---|---|---|---|
| Acpru /Id# 277377 | Grayslake | Illinois | 60030 | United States |
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| Placebo | Drug | IV Infusion |
|
CL for IV dosing. |
| Up to Approximately 113 Days |
| Immunogenicity of ABBV-8736 as Determined by Anti-Drug Antibodies (ADAs) | Incidence and concentrations of ADAs. Neutralizing ADAs (NAb) may be evaluated. | Up to Approximately 113 Days |