Safety and Tolerability in Healthy Subjects
Conditions
Keywords
cytokine inhibitor, IL-2, IL-9, IL-15
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.
Interventions
DRUGBNZ132-1-40
Injectable peptide antagonist of IL-2, IL-9 and IL-15
DRUGPlacebo
Normal Saline
Sponsors
Celerion
Bioniz Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Single-blind, placebo-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence, severity and relationship of treatment-emergent adverse events | 8 weeks | general safety evaluation by principal investigator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| single-dose and steady state AUC0-t | 8 weeks | plasma concentrations collected at multiple times after the first and last doses |
| Steady-state Elimination half-life (t1/2) | 8 weeks | plasma concentrations collected at multiple times after the last dose |
| single-dose and steady state Cmax | 8 weeks | plasma concentrations collected at multiple times after the first and last doses |
| Change from baseline for Natural Killer Cells | 8 weeks | Flow cytometry of PBMCs at multiple time points post dose |
| Change from baseline for CD8+ central memory T-cells (Tcm) | 8 weeks | Flow cytometry of PBMCs at multiple time points post dose |
| Change from baseline for Regulatory T-cells (Tregs) | 8 weeks | Flow cytometry of PBMCs at multiple time points post dose |
Countries
United States
Outcome results
None listed