A First-in-Human Study of BNZ132-1-40
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 6/23/2017 |
| Start Date: | November 2016 |
| End Date: | June 5, 2017 |
A First-in-human Study to Characterize the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of BNZ132-1-40
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.
profile of IV BNZ132-1-40, a novel peptide inhibitor of multiple cytokines in the IL-2
family.
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.
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.
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
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