Bacterial Infections
Conditions
Keywords
Healthy volunteers, Pharmacokinetics
Brief summary
This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of VNRX-5133 administered via intravenous (IV) infusion in healthy subjects. In part 1, subjects will receive a single dose of VNRX-5133; in part 2 subjects will receive VNRX-5133 for 7 days.
Interventions
DRUGVNRX-5133
DRUGPlacebo
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Venatorx Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults * Males or non-pregnant, non-lactating females * Body Mass Index (BMI) between 18.5 - 32.0, inclusive. * Suitable veins for cannulation
Exclusion criteria
* Employee of site or the sponsor * Any disease that poses an unacceptable risk to participants * Abnormal ECG * Abnormal labs * Abnormal vital signs * Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder * Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1 * Current smokers or history of smoking within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with adverse events; assessed by patient reporting, physical exams, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis. | Part 1: 8 days. Part 2: 17 days |
Countries
United States
Outcome results
None listed