Safety and Tolerability in Healthy SubjectsPhase 1NCT03239379
A Multiple-Dose Study of Intravenous BNZ132-1-40 in Healthy Adult Subjects
A Phase 1 study testing BNZ132-1-40 in people with Safety and Tolerability in Healthy Subjects, run by Bioniz Therapeutics at 1 site in United States.
Trial summary
This study is a single-center, randomized, single-blind, placebo (PBO)-controlled, multiple-dose study to characterize the safety, tolerability, PK, and PD of IV BNZ-1 administered to healthy adult subjects once weekly (QW) for 4 doses or once every other week (QOW) for 3 doses. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Tolerability in Healthy Subjects
- What is being tested?
- BNZ132-1-40
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2017to 8 Mar 2018
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoker.
- Weight ≤100 kg (due to drug supply limitations).
- Body Mass Index (BMI) ≥19 and <35 kg/m2.
- Healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital signs (pulse rate, blood pressure, respiratory rate), and ECG.
- Willing and able to consent and participate in the study.
- Subject agrees not to receive any other investigational product or therapy while participating in this study.
- Agrees to use adequate effective birth control methods prior to, during and for 30 days after the study.
Who cannot join
- Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult, or that would put the subject at risk by participating in the study in the opinion of the Investigator.
- History of cancer (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved).
- History of or currently active primary or secondary immunodeficiency.
- Known active bacterial, viral, fungal, mycobacterial infection, or other infection (including tuberculosis [TB] or atypical mycobacterial disease [but excluding fungal infection of nail beds, minor upper respiratory tract infection, and minor skin conditions]), or any major episode of infection that required hospitalization or treatment with IV antibiotics within 30 days of screening or oral antibiotics within 14 days prior to screening.
- Subject has received other investigational products or therapy in the past 30 days prior to study drug administration.
- Serologic evidence of human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
Show all 9Show fewer
- Subject has received an immunization within 14 days prior to study drug administration.
- History of alcohol or drug abuse within 1 year prior to screening.
- Subject requires the ongoing use of prescription medication other than oral contraceptives.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a single-center, randomized, single-blind, placebo (PBO)-controlled, multiple-dose study to characterize the safety, tolerability, PK, and PD of IV BNZ-1 administered to healthy adult subjects once weekly (QW) for 4 doses or once every other week (QOW) for 3 doses. Five cohorts of 6 subjects randomized 5 BNZ-1:1 PBO are planned to be enrolled in the trial. Participants will be followed for 4 weeks after the last dose for safety monitoring, and collection of PK and PD samples.
- Being tested
- BNZ132-1-40, Placebo
- Keywords
- cytokine inhibitor, IL-2, IL-9, IL-15
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNZ132-1-40Drug
Also called BNZ-1
Injectable peptide antagonist of IL-2, IL-9 and IL-15
PlaceboDrug
Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Normal saline Receives: Drug: Placebo |
| BNZ132-1-40 | Experimental | PEGylated BNZ-1 for Injection Receives: Drug: BNZ132-1-40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity and relationship of treatment-emergent adverse events
general safety evaluation by principal investigator
Measured: 8 weeks
Secondary outcomes (6)
single-dose and steady state Cmax
plasma concentrations collected at multiple times after the first and last doses
Measured: 8 weeks
single-dose and steady state AUC0-t
plasma concentrations collected at multiple times after the first and last doses
Measured: 8 weeks
Steady-state Elimination half-life (t1/2)
plasma concentrations collected at multiple times after the last dose
Measured: 8 weeks
Change from baseline for Regulatory T-cells (Tregs)
Flow cytometry of PBMCs at multiple time points post dose
Measured: 8 weeks
Change from baseline for Natural Killer Cells
Flow cytometry of PBMCs at multiple time points post dose
Measured: 8 weeks
Change from baseline for CD8+ central memory T-cells (Tcm)
Flow cytometry of PBMCs at multiple time points post dose
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start30 Oct 2017
- Primary completion15 Feb 2018
- Study completion8 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and Tolerability in Healthy SubjectsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 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
- NCT03239379
- Sponsor's protocol ID
- BNZ1-CT-102
- Status last verified
- May 2018
- First submitted
- 31 Jul 2017
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Dose Study of Intravenous BNZ132-1-40 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03239379
- Acronym / sponsor ID
- BNZ1-CT-102
- Keywords
- cytokine inhibitor, IL-2, IL-9, IL-15
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bioniz TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 8 Mar 2018 (actual)
- First posted
- 4 Aug 2017 (actual)
- 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 study is a single-center, randomized, single-blind, placebo (PBO)-controlled, multiple-dose study to characterize the safety, tolerability, PK, and PD of IV BNZ-1 administered to healthy adult subjects once weekly (QW) for 4 doses or once every other week (QOW) for 3 doses. Five cohorts of 6 subjects randomized 5 BNZ-1:1 PBO are planned to be enrolled in the trial. Participants will be followed for 4 weeks after the last dose for safety monitoring, and collection of PK and PD samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboNormal saline |
| BNZ132-1-40 | Experimental | Drug: BNZ132-1-40PEGylated BNZ-1 for Injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Non-smoker.
- Weight ≤100 kg (due to drug supply limitations).
- Body Mass Index (BMI) ≥19 and <35 kg/m2.
- Healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital signs (pulse rate, blood pressure, respiratory rate), and ECG.
- Willing and able to consent and participate in the study.
Key exclusion criteria (9 listed)
- Clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, renal, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult, or that would put the subject at risk by participating in the study in the opinion of the Investigator.
- History of cancer (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved).
- History of or currently active primary or secondary immunodeficiency.
- Known active bacterial, viral, fungal, mycobacterial infection, or other infection (including tuberculosis [TB] or atypical mycobacterial disease [but excluding fungal infection of nail beds, minor upper respiratory tract infection, and minor skin conditions]), or any major episode of infection that required hospitalization or treatment with IV antibiotics within 30 days of screening or oral antibiotics within 14 days prior to screening.
- Subject has received other investigational products or therapy in the past 30 days prior to study drug administration.
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 |
|---|---|---|
| BNZ132-1-40Also: BNZ-1Injectable peptide antagonist of IL-2, IL-9 and IL-15 | Drug | BNZ132-1-40 |
| PlaceboNormal Saline | Drug | Placebo |
Primary outcome
Incidence, severity and relationship of treatment-emergent adverse events
Time frame: 8 weeks
general safety evaluation by principal investigator
6 secondary outcomes
single-dose and steady state Cmax
Time frame: 8 weeks
single-dose and steady state AUC0-t
Time frame: 8 weeks
Steady-state Elimination half-life (t1/2)
Time frame: 8 weeks
Change from baseline for Regulatory T-cells (Tregs)
Time frame: 8 weeks
Change from baseline for Natural Killer Cells
Time frame: 8 weeks
Change from baseline for CD8+ central memory T-cells (Tcm)
Time frame: 8 weeks
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 15 May 2018.
- 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 Safety and Tolerability in Healthy Subjects, 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 7 inclusion and 9 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 15 May 2018. 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. Some participants in this study may receive a placebo. 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?
Incidence, severity and relationship of treatment-emergent adverse events (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2018; AzTrials last refreshed its copy on 6 Nov 2026.