Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to assess the pharmacokinetic properties, safety, tolerability, and immunogenicity of ABBV-142 and determine whether predicted efficacious exposures can be safely achieved in humans.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Group 1 | Experimental | Participants will receive ABBV-142 Dose A or Placebo on Day 1. |
|
| Part 1: Group 2 | Experimental | Participants will receive ABBV-142 Dose B or Placebo on Day 1. |
|
| Part 1: Group 3 | Experimental | Participants will receive ABBV-142 Dose C or Placebo on Day 1. |
|
| Part 1: Group 4 | Experimental | Participants will receive ABBV-142 Dose D or Placebo on Day 1. |
|
| Part 1: Group 5 (Optional) | Experimental | Participants will receive ABBV-142 Dose TBD or Placebo on Day 1. |
|
| Part 2: Group 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-142 | Drug | Intravenous (IV) Infusion |
|
| 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 Day 120 |
| Maximum Observed Serum Concentration (Cmax) of ABBV-142 | Cmax of ABBV-142 will be assessed. | Up to Day 120 |
| Time to Cmax (Tmax) of ABBV-142 | Tmax of ABBV-142 will be assessed. | Up to Day 120 |
| Area Under the Serum Concentration-time Curve (AUC) of ABBV-142 from Time 0 to the Time of Last Measurable Concentration (AUCt) | AUCt of ABBV-142 will be determined. | Up to Day 120 |
| AUC of ABBV-142 from Time 0 to Infinity (AUCinf) | AUCinf of ABBV-142 will be assessed. | Up to Day 120 |
| Terminal Phase Elimination Rate Constant (β) of ABBV-142 | Terminal phase elimination rate constant (β) of ABBV-142 will be assessed. | Up to Day 120 |
| Terminal Phase Elimination Half-life (t1/2) of ABBV-142 | Terminal phase elimination half-life (t1/2) of ABBV-142 will be assessed. | Up to Day 120 |
Not provided
Not provided
Inclusion Criteria:
All Parts:
• Volunteers in general good health.
Part 3, ONLY:
HAN CHINESE Participants:
OR
JAPANESE Participants:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acpru /Id# 271899 | Grayslake | Illinois | 60030 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will receive ABBV-142 Dose B or Placebo on Day 1.
|
| Part 2: Group 7 | Experimental | Participants will receive ABBV-142 Dose C or Placebo on Day 1. |
|
| Part 3: Group 8 | Experimental | Han Chinese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1. |
|
| Part 3: Group 9 | Experimental | Japanese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1. |
|
| ABBV-142 | Drug | Subcutaneous (SC) Injection |
|
| Placebo | Drug | IV Infusion |
|
| Placebo | Drug | SC Injection |
|
| Dose Normalized Cmax of ABBV-142 |
Dose normalized Cmax of ABBV-142 will be assessed. |
| Up to Day 120 |
| Dose Normalized AUC of ABBV-142 | Dose normalized AUC of ABBV-142 will be assessed. | Up to Day 120 |