Clinical trial NCT03239379: A Multiple-Dose Study of Intravenous BNZ132-1-40 in Healthy Adult Subjects
Official title: A Multiple-Dose Study of Intravenous BNZ132-1-40 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety and Tolerability in Healthy Subjects
Keywords: cytokine inhibitor
IL-2
IL-9
IL-15
Lead sponsor: Bioniz Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Celerion
First posted: 2017-08-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Non-smoker.
2. Weight ≤100 kg (due to drug supply limitations).
3. Body Mass Index (BMI) ≥19 and \<35 kg/m2.
4. Healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital signs (pulse rate, blood pressure, respiratory rate), and ECG.
5. Willing and able to consent and participate in the study.
6. Subject agrees not to receive any other investigational product or therapy while participating in this study.
7. Agrees to use adequate effective birth control methods prior to, during and for 30 days after the study.

Exclusion Criteria:

1. 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.
2. History of cancer (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved).
3. History of or currently active primary or secondary immunodeficiency.
4. 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.
5. Subject has received other investigational products or therapy in the past 30 days prior to study drug administration.
6. Serologic evidence of human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.
7. Subject has received an immunization within 14 days prior to study drug administration.
8. History of alcohol or drug abuse within 1 year prior to screening.
9. Subject requires the ongoing use of prescription medication other than oral contraceptives.

Primary outcomes:
measure: Incidence, severity and relationship of treatment-emergent adverse events
timeFrame: 8 weeks
Secondary outcomes:
measure: single-dose and steady state Cmax
timeFrame: 8 weeks
measure: single-dose and steady state AUC0-t
timeFrame: 8 weeks
measure: Steady-state Elimination half-life (t1/2)
timeFrame: 8 weeks
measure: Change from baseline for Regulatory T-cells (Tregs)
timeFrame: 8 weeks
measure: Change from baseline for Natural Killer Cells
timeFrame: 8 weeks
measure: Change from baseline for CD8+ central memory T-cells (Tcm)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Bioniz Therapeutics, Inc.
name: Paul A Frohna, MD, PhD
role: STUDY_DIRECTOR
References: