HealthyPhase 1NCT03046459
A First-in-Human Study of BNZ132-1-40
A Phase 1 study testing BNZ132-1-40 in people with Healthy, run by Bioniz Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BNZ132-1-40
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 5 Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Recent systemic infections
- Clinically-significant abnormal clinical labs, ECG or physical examination
- Immunization 30 days prior to study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- BNZ132-1-40
- Keywords
- cytokines, interleukin-2, Safety Issues
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNZ132-1-40Biological
pegylated peptide inhibiting IL-2, IL-9 and IL-15
| Study group | Role | What they receive |
|---|---|---|
| BNZ132-1-40 | Experimental | a range of IV doses Receives: Biological: BNZ132-1-40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with related, treatment-emergent adverse events
Measured: 30 days
Secondary outcomes (3)
PK: Exposure as determined by maximum plasma concentration (Cmax)
Measured: 1 Day
PK: Exposure as determined by area under the concentration-time curve (AUC)
Measured: 30 days
PD: Effects of BNZ132-1-40 on the expression of T cells as determined by FACS analysis
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study startNov 2016
- Primary completion5 Jun 2017
- Study completion5 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioniz Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Sponsor
- Investigators
- Paul A Frohna, MD, PhD, Study director, Bioniz Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046459
- Sponsor's protocol ID
- BNZ-CT-101
- Status last verified
- Jun 2017
- First submitted
- 25 Jan 2017
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nata T, Basheer A, Cocchi F, van Besien R, Massoud R, Jacobson S, Azimi N, Tagaya Y. Targeting the binding interface on a shared receptor subunit of a cytokine family enables the inhibition of multiple member cytokines with selectable target spectrum. J Biol Chem. 2015 Sep 11;290(37):22338-51. doi: 10.1074/jbc.M115.661074. Epub 2015 Jul 16.
PubMed 26183780
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human Study to Characterize the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of BNZ132-1-40
- ClinicalTrials.gov ID
- NCT03046459
- Acronym / sponsor ID
- BNZ-CT-101
- Conditions
- Healthy
- Keywords
- cytokines, interleukin-2, Safety Issues
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Bioniz TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- Nov 2016 (actual)
- Primary completion
- 5 Jun 2017 (actual)
- Study completion
- 5 Jun 2017 (actual)
- First posted
- 8 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BNZ132-1-40 | Experimental | Biological: BNZ132-1-40a range of IV doses |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Recent systemic infections
- Clinically-significant abnormal clinical labs, ECG or physical examination
- Immunization 30 days prior to study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNZ132-1-40pegylated peptide inhibiting IL-2, IL-9 and IL-15 | Biological | BNZ132-1-40 |
Primary outcome
The proportion of subjects with related, treatment-emergent adverse events
Time frame: 30 days
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Background: PubMed 26183780Nata T, Basheer A, Cocchi F, van Besien R, Massoud R, Jacobson S, Azimi N, Tagaya Y. Targeting the binding interface on a shared receptor subunit of a cytokine family enables the inhibition of multiple member cytokines with selectable target spectrum. J Biol Chem. 2015 Sep 11;290(37):22338-51. doi: 10.1074/jbc.M115.661074. Epub 2015 Jul 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul A Frohna, MD, PhD study director
Bioniz Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BNZ132-1-40 in people with Healthy, run by Bioniz Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects with related, treatment-emergent adverse events (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03046459, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.