Healthy
Conditions
Keywords
cytokines, interleukin-2, Safety Issues
Brief summary
This is an open-label, single ascending dose study to characterize the safety and PK/PD profile of IV BNZ132-1-40, a novel peptide inhibitor of multiple cytokines in the IL-2 family.
Detailed description
This is a open-label study of single doses of intravenous BNZ132-1-40 administered to healthy adult subjects. Subjects are followed for 30 days after treatment for collection of safety, PK and PD data. Cohorts of up to 6 subjects will be enrolled for each dose level.
Interventions
BIOLOGICALBNZ132-1-40
pegylated peptide inhibiting IL-2, IL-9 and IL-15
Sponsors
Celerion
Bioniz Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* males and non-pregnant, non-lactating females * no ongoing clinically significant medical condition * willing and able to provide informed consent * no use of Rx or OTC medications, other than oral contraceptives
Exclusion criteria
* Recent systemic infections * Clinically-significant abnormal clinical labs, ECG or physical examination * Immunization 30 days prior to study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with related, treatment-emergent adverse events | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| PK: Exposure as determined by maximum plasma concentration (Cmax) | 1 Day |
| PK: Exposure as determined by area under the concentration-time curve (AUC) | 30 days |
| PD: Effects of BNZ132-1-40 on the expression of T cells as determined by FACS analysis | 30 days |
Countries
United States
Outcome results
None listed