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The objective of this study is to assess the pharmacokinetic (PK), immunogenicity, safety, and tolerability of ABBV-1451 after single ascending doses in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Group 1 | Experimental | Participants will receive either single ascending doses of ABBV-1451 until they reach Dose A or placebo. |
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| Part 1: Group 2 | Experimental | Participants will receive either single ascending doses of ABBV-1451 until they reach Dose B or placebo. |
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| Part 1: Group 3 | Experimental | Participants will receive either single ascending doses of ABBV-1451 until they reach Dose C or placebo. |
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| Part 1: Group 4 | Experimental | Participants will receive either single ascending doses of ABBV-1451 until they reach Dose A or placebo. |
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| Part 1: Group 5 | Experimental | Participants will receive either single ascending doses of ABBV-1451 until they reach Dose C or placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-1451 | 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. The investigator assesses the relationship of each event to the use of study. | Up to Approximately Day 211 |
| Maximum Observed Plasma Concentration (Cmax) of ABBV-1451 | Cmax of ABBV-1451. | Up to Approximately Day 211 |
| Time to Cmax (Tmax) of ABBV-1451 | Tmax of ABBV-1451. | Up to Approximately Day 211 |
| Terminal Phase Elimination Rate Constant (β) of ABBV-1451 | β of ABBV-1451. | Up to Approximately Day 211 |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-1451 | t1/2 of ABBV-1451. | Up to Approximately Day 211 |
| Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-1451 | AUCt of ABBV-1451. | Up to Approximately Day 211 |
| Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-1451 | AUCinf of ABBV-1451. | Up to Approximately Day 211 |
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Inclusion Criteria:
A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
Applies to Part 2 only:
For Japanese participants:
-- Participant must be first or second-generation Japanese of full Japanese parentage, residing outside of Japan. First generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. Participants must be in general good health.
For Han Chinese participants:
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# 282128 | Recruiting | Grayslake | Illinois | 60030 | United States |
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| Part 1: Group 6 |
| Experimental |
Participants will receive either single ascending doses of ABBV-1451 until they reach Dose TBD or placebo. |
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| Part 2: Group 7 | Experimental | Japanese participants will receive a single dose of ABBV-1451 Dose C or placebo. |
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| Part 2: Group 8 | Experimental | Han Chinese participants will receive a single dose of ABBV-1451 Dose C or placebo. |
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| ABBV-1451 |
| Drug |
Infusion |
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| Placebo | Other | Injection |
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| Placebo | Other | Infusion |
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