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The purpose of this study is to compare the bioavailability of two different formulations of lutikizumab, and to assess adverse events (AEs) and how lutikizumab moves through the body in healthy Chinese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1, Dose A | Experimental | Participants will receive a single dose of Lutikizumab Dose A. |
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| Part 1, Dose B | Experimental | Participants will receive a single dose of Lutikizumab Dose B. |
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| Part 2 | Experimental | Han Chinese participants will receive a single dose of Lutikizumab. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lutikizumab Dose A | Drug | Injection; subcutaneous (SC) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of Lutikizumab | Cmax of lutikizumab will be assessed. | Up to Day 8 |
| Time to Cmax (Tmax) of Lutikizumab | Tmax of lutikizumab will be assessed. | Up to Day 8 |
| Apparent Terminal Phase Elimination Rate Constant (β) of Lutikizumab | Apparent terminal phase elimination rate constant (β) of lutikizumab will be assessed. | Up to Day 8 |
| Terminal Phase Elimination Half-life (t1/2) of Lutikizumab | Terminal phase elimination half-life (t1/2) of lutikizumab will be assessed. | Up to Day 8 |
| Area under the Serum Concentration-time Curve (AUC) from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of Lutikizumab | AUC0-t of lutikizumab will be assessed. | Up to Day 8 |
| AUC from Time 0 to Infinity (AUC0-inf) of Lutikizumab | AUC0-inf of lutikizumab will be assessed. | Up to Day 8 |
| 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 71 |
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Inclusion Criteria:
Male and female healthy volunteers aged between 18 and 60 years.
-- Part 2 only: Participant must be first-generation Han Chinese of full Chinese parentage residing outside of China. Participant must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
BMI <= 18.0 to <= 29.9 kg/m^2 after rounding to the tenths decimal, at screening and upon initial confinement.
A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and 12-lead electrocardiogram (ECG).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences Clinical Los Angeles, Inc /ID# 260986 | Cypress | California | 90630 | United States | ||
| Acpru /Id# 259029 |
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| Lutikizumab Dose B |
| Drug |
Injection; subcutaneous (SC) |
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| Grayslake |
| Illinois |
| 60030 |
| United States |
| PPD Clinical Research Unit - Austin /ID# 260141 | Austin | Texas | 78744 | United States |