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The purpose of this study is to evaluate the relative bioavailability of Povetacicept formulations, bioequivalence of Povetacicept presentations, and safety and tolerability of Povetacicept.
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A1: Povetacicept Bioavailability | Experimental | Participants will be randomized to receive one of the two Povetacicept formulations. |
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| Part A2: Povetacicept Bioavailability | Experimental | Participants will be randomized to receive one of the two Povetacicept formulations. |
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| Part B1: Povetacicept Bioequivalence | Experimental | Participants will be randomized to receive one of the two Povetacicept presentations. |
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| Part B2: Povetacicept Bioequivalence | Experimental | Participants will be randomized to receive one of the two Povetacicept presentations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povetacicept | Drug | Injection for Subcutaneous Administration. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Versus Time Curve From the Time of Dosing to 28 Days (AUC0-28d) of Free Povetacicept | From Day 1 up to Day 30 | |
| Maximum Observed Plasma Concentration (Cmax) of Free Povetacicept | From Day 1 up to Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Day 1 up to Day 31 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion - Tempe | Tempe | Arizona | 85283 | United States | ||
| Celerion - Lincoln |
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing
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| Lincoln |
| Nebraska |
| 68502 |
| United States |