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The main objective is to assess the safety and tolerability of subcutaneous and intravenous injection forms of budoprutug in healthy volunteers.
Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity. This Phase 1, randomized, double-blind, placebo-controlled, single-ascending-dose study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of budoprutug administered subcutaneously (SC) in adult normal healthy volunteers (NHVs). To assess the bioavailability of the SC formulation, one cohort will receive a single intravenous (IV) dose of budoprutug. Approximately 38 participants will be enrolled across four dose cohorts, including three SC dose levels and one IV comparator group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budoprutug | Experimental | Subcutaneous (SC) injection or IV administration of budoprutug |
|
| Placebo | Placebo Comparator | Placebo solution to be administered at a matching volume |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budoprutug | Drug | Subcutaneous or IV administration |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of Single Ascending Doses of budoprutug in Healthy Participants | Incidence of treatment-emergent adverse events | Day 57 |
| Incidence of infusion-related reactions (IRRs) for IV administration | Number of infusion-related reactions | Day 57 |
| Incidence of injection site reactions (ISRs) for SC administration | Number of injection site reactions | Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Measurement of the maximum observed plasma concentration. | Day 57 |
| Time to Maximum Observed Concentration (Tmax) | Measurement of the time to maximum observed concentration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network Brisbane | Brisbane | Australia |
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| Placebo | Drug | Placebo comparator |
|
| Day 57 |
| Area Under the Curve (AUC) | Measurement of the area under the drug concentration-time curve. | Day 57 |
| Terminal Half-Life (T1/2) | Measurement of the terminal half-life in days. | Day 57 |
| Bioavailability (F) | Relative absorption of SC vs IV budoprutug (%). | Day 57 |