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The objective of this study is to assess the bioavailability of risankizumab liquid vial manufactured with the new process (CMC3) relative to the current process (CMC2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Participants will receive risankizumab manufactured with using the current process (CMC2). |
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| Arm 2 | Active Comparator | Participants will receive risankizumab manufactured with using the new process (CMC3). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risankizumab | Drug | Infusion; intravenous |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) | Cmax will be assessed. | Up to Day 131 |
| Time to Cmax (Tmax) | Tmax will be assessed. | Up to Day 131 |
| Apparent Terminal Phase Elimination Rate Constant (β) | Apparent terminal phase elimination rate constant (β) will be assessed. | Up to Day 131 |
| Terminal Phase Elimination Half-life (t1/2) | Terminal phase elimination half-life (t1/2) will be assessed. | Up to Day 131 |
| Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t) | AUC0-t will be assessed. | Up to Day 131 |
| AUC from Time 0 to Infinity (AUC0-inf) | AUC0-inf will be assessed. | Up to Day 131 |
| Number of Participants with Adverse Events (AEs) | 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. | Baseline to Day 141 |
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Inclusion Criteria:
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# 260740 | Anaheim | California | 92801-2658 | United States | ||
| Clinical Pharmacology of Miami /ID# 260800 |
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| ID | Term |
|---|---|
| C000601773 | risankizumab |
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| Miami |
| Florida |
| 33014 |
| United States |
| Acpru /Id# 260864 | Grayslake | Illinois | 60030 | United States |