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This study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab administered SC as a single injection via PFS-NSD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1: Needle and Syringe | Experimental | Healthy volunteers will receive a single SC injection of lebrikizumab, withdrawn from a vial and administered by a needle and syringe. |
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| Treatment 2: PFS-NSD | Experimental | Healthy volunteers will receive a single SC injection of lebrikizumab, administered by PFS-NSD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lebrikizumab | Drug | Participants will receive a single SC dose of lebrikizumab, delivered via needle and syringe or PFS-NSD. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) of lebrikizumab | Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months) | |
| Time to maximum concentration (Tmax) of lebrikizumab | Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months) | |
| Area under the concentration-time curve to the last measurable concentration (AUC0-last) of lebrikizumab | Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months) | |
| Area under the concentration-time curve extrapolated to infinity (AUC0-inf) of lebrikizumab | Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months) | |
| Apparent terminal elimination rate constant of lebrikizumab | Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months) | |
| Apparent terminal elimination half-life (t1/2) of lebrikizumab | Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months) | |
| Apparent clearance (CL/F) of lebrikizumab | Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months) | |
| Apparent volume of distribution (Vz/F) of lebrikizumab | Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | From Day -1 until study completion or premature withdrawal (up to approximately 3 months) | |
| Incidence of anti-therapeutic antibodies (ATAs) to lebrikizumab | From Day 1 until study completion or premature withdrawal (up to approximately 3 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daytona Beach | Florida | 32117 | United States | |||
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| Evansville |
| Indiana |
| 47710 |
| United States |
| Dallas | Texas | 75247 | United States |
| Madison | Wisconsin | 53704 | United States |
| ID | Term |
|---|---|
| C561806 | lebrikizumab |
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