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The objective of this study is to evaluate the safety, tolerability, immunogenicity and pharmacokinetics (PK ) properties following a single dose of ABBV-277 in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: ABBV-277-Dose A | Experimental | Participants will receive ABBV-277 Dose A on day 1 and followed for 196 days |
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| Group 1: Placebo | Experimental | Participants will receive Placebo on day 1 and followed for 196 days |
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| Group 2: ABBV-277-Dose B | Experimental | Participants will receive ABBV-277 Dose B on day 1 and followed for 196 days |
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| Group 2: Placebo | Experimental | Participants will receive Placebo on day 1 and followed for 196 days |
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| Group 3: ABBV-277-Dose C | Experimental | Participants will receive ABBV-277 Dose C on day 1 and followed for 196 days |
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| Group 3: Placebo | Experimental | Participants will receive Placebo on day 1 and followed for 196 days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-277 | Drug | • Intravenous (IV) infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of ABBV-277 | Cmax of ABBV-277 | Up to approximately 9 days |
| Time to Cmax (Tmax) of ABBV-277 | Tmax of ABBV-277 | Up to approximately 9 days |
| Terminal Phase Elimination Rate Constant (Beta) of ABBV-277 | Terminal phase elimination rate constant (beta) of ABBV-277 | Up to approximately 9 days |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-277 | Terminal phase elimination half-life of ABBV-277 | Up to approximately 9 days |
| Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-277 | AUCt of ABBV-277 | Up to approximately 9 days |
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-277 | AUCinf of ABBV-277 | Up to approximately 9 days |
| Number of Participants With 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. The investigator assesses the relationship of each event to the use of study | Up to Day 196 |
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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# 265681 | Grayslake | Illinois | 60030 | United States |
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| Group 4: ABBV-277-Dose D | Experimental | Participants will receive ABBV-277 Dose D on day 1 and followed for 196 days |
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| Group 4: Placebo | Experimental | Participants will receive Placebo on day 1 and followed for 196 days |
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| Group 5: ABBV-277-Dose E | Experimental | Participants will receive ABBV-277 Dose E on day 1 and day 2 and followed for 196 days |
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| Group 5: Placebo | Experimental | Participants will receive Placebo on day 1 and day 2 and followed for 196 days |
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| Placebo | Drug | • Intravenous (IV) infusion |
|