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The main objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity of single ascending doses of ABBV-701 in healthy adult western and Asian participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Group 1 ABBV-701 or Placebo | Experimental | Participants will receive a single dose of either ABBV-701 Dose A or placebo. |
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| Part 1: Group 2 ABBV-701 or Placebo | Experimental | Participants will receive a single dose of either ABBV-701 Dose B or placebo. |
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| Part 1: Group 3 ABBV-701 or Placebo | Experimental | Participants will receive a single dose of either ABBV-701 Dose C or placebo. |
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| Part 1: Group 4 ABBV-701 or Placebo | Experimental | Participants will receive a single dose of either ABBV-701 Dose D or placebo. |
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| Part 1: Group 5 ABBV-701 or Placebo | Experimental | Participants will receive a single dose of either ABBV-701 Dose E or placebo. |
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| Part 2: Group 6 ABBV-701 or Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-701 | Drug | Subcutaneous |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events | An 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. | Up to approximately 47 weeks |
| Maximum Plasma Concentration (Cmax) of ABBV-701 | Cmax of ABBV-701 | Up to approximately 47 weeks |
| Time to Cmax (Tmax) of ABBV-701 | Tmax of ABBV-701 | Up to approximately 47 weeks |
| Apparent terminal phase elimination rate constant (β) of ABBV-701 | (β) of ABBV-701 | Up to approximately 47 weeks |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-701 | (t1/2) of ABBV-701 | Up to approximately 47 weeks |
| Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-701 | AUCt of ABBV-701 | Up to approximately 47 weeks |
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-701 | AUCinf of ABBV-701 | Up to approximately 47 weeks |
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Inclusion Criteria:
For Japanese Participants:
--Participant must be first or second-generation Japanese parentage (both parents of Japanese descent), residing outside of Japan. Participants must be in general good health and maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.
Han Chinese Participants:
--Participant must be first or second-generation Han Chinese of full Chinese parentage (both parents of Han Chinese descent), residing outside of China. Participants must be in general good health and maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
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# 278431 | Anaheim | California | 92801 | United States | ||
| Acpru /Id# 273354 |
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| Experimental |
Participants will receive a single dose of either ABBV-701 Dose E or placebo. |
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| Part 2: Group 7 ABBV-701 or Placebo | Experimental | Participants will receive a single dose of either ABBV-701 Dose E or placebo. |
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| Part 3: Group 8 ABBV-701 or Placebo | Experimental | Participants will receive a single dose of either ABBV-701 Dose C or placebo. |
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| Part 3: Group 9 ABBV-701 or Placebo | Experimental | Participants will receive a single dose of either ABBV-701 Dose E or placebo. |
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| Part 3: Group 10 ABBV-701 or Placebo | Experimental | Participants will receive a single dose of either ABBV-701 Dose F or placebo. |
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| Part 4: Group 11 ABBV-701 or Placebo | Experimental | Participants will receive a single dose of either ABBV-701 Dose F or placebo. |
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| Part 4: Group 12 ABBV-701 or Placebo | Experimental | Participants will receive a single dose of either ABBV-701 Dose F or placebo. |
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| Placebo | Drug | Subcutaneous |
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| ABBV-701 | Drug | IV Infusion |
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| Placebo | Drug | IV infusion |
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| Grayslake |
| Illinois |
| 60030 |
| United States |