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This study will assess how safe ABBV-154 is and how ABBV-154 moves through the body of adult healthy participants. Adverse Events will be assessed.
ABBV-154 is an investigational drug being developed for potential treatment of immune-mediated inflammatory diseases. Participants are randomly assigned to one of the 2 treatment groups. Approximately 40 adult healthy volunteers will be enrolled in 2 sites in the United States.
All participants will receive ABBV-154 as subcutaneous injections with one of the 2 different formulations.
There may be higher burden for participants in this trial. Participants will be confined for 9 days. Adverse Events and blood tests will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBV-154 Dose A | Experimental | Participants will receive subcutaneous dose of ABBV-154 Dose Formulation A. |
|
| ABBV-154 Dose B | Experimental | Participants will receive subcutaneous dose of ABBV-154 Dose Formulation B. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-154 Dose Formulation A | Drug | Subcutaneous Injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Maximum Observed Plasma Concentration (Cmax) | Approximately up to 58 days |
| Time to Maximum Observed Plasma Concentration (Tmax) | Time to Maximum Observed Plasma Concentration (Tmax) | Approximately up to 58 days |
| Apparent Terminal Phase Elimination Rate Constant (β) | Apparent Terminal Phase Elimination Rate Constant (β) | Approximately up to 58 days |
| The Terminal Phase Elimination Half-Life (t1/2) | The Terminal Phase Elimination Half-Life (t1/2) | Approximately up to 58 days |
| The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt) | The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt) | Approximately up to 58 days |
| The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞) | The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞) | Approximately up to 58 days |
| Number of Participants with Adverse Events | 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. |
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Inclusion Criteria:
- Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounding to the nearest tenth at screening and upon initial confinement.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acpru /Id# 250429 | Grayslake | Illinois | 60030 | United States | ||
| PPD Clinical Research Unit -Las Vegas /ID# 250650 |
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| ABBV-154 Dose Formulation B |
| Drug |
Subcutaneous Injection |
|
| Approximately up to 72 days |
| Las Vegas |
| Nevada |
| 89113-2235 |
| United States |