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This study will assess how safe risankizumab is and how risankizumab moves through the body of adult healthy participants. Adverse Events will be assessed.
Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease. Participants are randomly assigned to one of the 2 treatment groups. Approximately 198 adult healthy volunteers will be enrolled in at least 4 sites across the world.
All participants will receive risankizumab as subcutaneous injections in one of the 2 different formulations.
There may be higher burden for participants in this trial. Participants will be confined for 10 days and followed up for 140 days. Adverse Events and blood tests will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risankizumab Dose A | Experimental | Participants will receive subcutaneous dose of risankizumab dose A. |
|
| Risankizumab Dose B | Experimental | Participants will receive subcutaneous dose of risankizumab dose B. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risankizumab Dose A | Drug | Prefilled Syringe |
| |
| Risankizumab Dose B |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Maximum Observed Plasma Concentration (Cmax) | Approximately up to 113 days |
| Time to Maximum Observed Plasma Concentration (Tmax) | Time to Maximum Observed Plasma Concentration (Tmax) | Approximately up to 113 days |
| Apparent Terminal Phase Elimination Rate Constant (β) | Apparent Terminal Phase Elimination Rate Constant (β) | Approximately up to 113 days |
| The Terminal Phase Elimination Half-Life (t1/2) | The Terminal Phase Elimination Half-Life (t1/2) | Approximately up to 113 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 113 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 113 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 weight greater than 40 kg and less than 100 kg 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 |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials LLC /ID# 250098 | Anaheim | California | 92801-2658 | United States | ||
| Clinical Pharmacology of Miami /ID# 250099 |
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| Drug |
Prefilled Syringe |
|
| Approximately up to 140 days |
| Miami |
| Florida |
| 33014 |
| United States |
| Acpru /Id# 249681 | Grayslake | Illinois | 60030 | United States |
| Bio-Kinetic Clinical Applications, LLC /ID# 250181 | Springfield | Missouri | 65802 | United States |
| PPD Clinical Research Unit - Austin /ID# 250672 | Austin | Texas | 78744 | United States |