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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
32
Injectable peptide antagonist of IL-2, IL-9 and IL-15
Normal Saline
Celerion
Tempe, Arizona, United States
Incidence, severity and relationship of treatment-emergent adverse events
general safety evaluation by principal investigator
Time frame: 8 weeks
single-dose and steady state Cmax
plasma concentrations collected at multiple times after the first and last doses
Time frame: 8 weeks
single-dose and steady state AUC0-t
plasma concentrations collected at multiple times after the first and last doses
Time frame: 8 weeks
Steady-state Elimination half-life (t1/2)
plasma concentrations collected at multiple times after the last dose
Time frame: 8 weeks
Change from baseline for Regulatory T-cells (Tregs)
Flow cytometry of PBMCs at multiple time points post dose
Time frame: 8 weeks
Change from baseline for Natural Killer Cells
Flow cytometry of PBMCs at multiple time points post dose
Time frame: 8 weeks
Change from baseline for CD8+ central memory T-cells (Tcm)
Flow cytometry of PBMCs at multiple time points post dose
Time frame: 8 weeks
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