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| Name | Class |
|---|---|
| Celerion | INDUSTRY |
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This study is a single-center, randomized, single-blind, placebo (PBO)-controlled, multiple-dose study to characterize the safety, tolerability, PK, and PD of IV BNZ-1 administered to healthy adult subjects once weekly (QW) for 4 doses or once every other week (QOW) for 3 doses. Five cohorts of 6 subjects randomized 5 BNZ-1:1 PBO are planned to be enrolled in the trial. Participants will be followed for 4 weeks after the last dose for safety monitoring, and collection of PK and PD samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Normal saline |
|
| BNZ132-1-40 | Experimental | PEGylated BNZ-1 for Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BNZ132-1-40 | Drug | Injectable peptide antagonist of IL-2, IL-9 and IL-15 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, severity and relationship of treatment-emergent adverse events | general safety evaluation by principal investigator | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| single-dose and steady state Cmax | plasma concentrations collected at multiple times after the first and last doses | 8 weeks |
| single-dose and steady state AUC0-t | plasma concentrations collected at multiple times after the first and last doses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul A Frohna, MD, PhD | Bioniz Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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Single-blind, placebo-controlled
| Placebo | Drug | Normal Saline |
|
| 8 weeks |
| Steady-state Elimination half-life (t1/2) | plasma concentrations collected at multiple times after the last dose | 8 weeks |
| Change from baseline for Regulatory T-cells (Tregs) | Flow cytometry of PBMCs at multiple time points post dose | 8 weeks |
| Change from baseline for Natural Killer Cells | Flow cytometry of PBMCs at multiple time points post dose | 8 weeks |
| Change from baseline for CD8+ central memory T-cells (Tcm) | Flow cytometry of PBMCs at multiple time points post dose | 8 weeks |