A First-in-Human Study of BNZ132-1-40
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Biological: BNZ132-1-40
- Registration Number
- NCT03046459
- Lead Sponsor
- Bioniz Therapeutics
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BNZ132-1-40 BNZ132-1-40 a range of IV doses
- Primary Outcome Measures
Name Time Method The proportion of subjects with related, treatment-emergent adverse events 30 days
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Celerion
🇺🇸Phoenix, Arizona, United States