A First-in-Human Study of BNZ132-1-40
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03046459 |
Recruitment Status :
Completed
First Posted : February 8, 2017
Last Update Posted : June 22, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Biological: BNZ132-1-40 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | A First-in-human Study to Characterize the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of BNZ132-1-40 |
Actual Study Start Date : | November 2016 |
Actual Primary Completion Date : | June 5, 2017 |
Actual Study Completion Date : | June 5, 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: BNZ132-1-40
a range of IV doses
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Biological: BNZ132-1-40
pegylated peptide inhibiting IL-2, IL-9 and IL-15 |
- The proportion of subjects with related, treatment-emergent adverse events [ Time Frame: 30 days ]
- PK: Exposure as determined by maximum plasma concentration (Cmax) [ Time Frame: 1 Day ]
- PK: Exposure as determined by area under the concentration-time curve (AUC) [ Time Frame: 30 days ]
- PD: Effects of BNZ132-1-40 on the expression of T cells as determined by FACS analysis [ Time Frame: 30 days ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03046459
United States, Arizona | |
Celerion | |
Phoenix, Arizona, United States, 85283 |
Study Director: | Paul A Frohna, MD, PhD | Bioniz Therapeutics, Inc. |
Publications:
Responsible Party: | Bioniz Therapeutics |
ClinicalTrials.gov Identifier: | NCT03046459 |
Other Study ID Numbers: |
BNZ-CT-101 |
First Posted: | February 8, 2017 Key Record Dates |
Last Update Posted: | June 22, 2017 |
Last Verified: | June 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
cytokines interleukin-2 Safety Issues |