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The objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity of single and multiple doses of ABBV-313 in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1, Group 1: ABBV-313 or Placebo | Experimental | Participants will receive a single dose of ABBV-313 or Placebo |
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| Part 1, Group 2: ABBV-313 or Placebo | Experimental | Participants will receive a single dose of ABBV-313 or Placebo |
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| Part 1, Group 3: ABBV-313 or Placebo | Experimental | Participants will receive a single dose of ABBV-313 or Placebo |
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| Part 1, Group 4: ABBV-313 or Placebo | Experimental | Participants will receive a single dose of ABBV-313 or Placebo |
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| Part 1, Group 5: ABBV-313 or Placebo | Experimental | Participants will receive a single dose of ABBV-313 or Placebo |
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| Part 1, Group 6: ABBV-313 or Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-313 | Drug | 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 Approximately Day 329 |
| Maximum Observed Plasma Concentration (Cmax) of ABBV-313 | Cmax of ABBV-313. | Up to Approximately Day 329 |
| Time to Cmax (Tmax) of ABBV-313 | Tmax of ABBV-313. | Up to Approximately Day 329 |
| Terminal Phase Elimination Rate Constant (Beta) of ABBV-313 | Beta of ABBV-313. | Up to Approximately Day 329 |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-313 | t1/2 of ABBV-313. | Up to Approximately Day 329 |
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-313 | AUCt of ABBV-313. | Up to Approximately Day 329 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acpru /Id# 283495 | Recruiting | Grayslake | Illinois | 60030 | United States |
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| Experimental |
Participants will receive a single dose of ABBV-313 or Placebo |
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| Part 2, Group 7: ABBV-313 or Placebo | Experimental | Participants will receive multiple doses of ABBV-313 or Placebo |
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| Part 2, Group 8: ABBV-313 or Placebo | Experimental | Participants will receive multiple doses of ABBV-313 or Placebo |
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| Placebo | Drug | Injection |
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| ABBV-313 | Drug | Infusion |
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| Placebo | Drug | Infusion |
|