Healthy Subjects
Conditions
Brief summary
This is a 2-part dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-5024. Subjects will be enrolled in one of three dose cohorts. They will receive a single dose on Day 1 in Part 1 and will proceed into the multiple dose Part 2 of the study after safety assessments and PK samples are collected. In the multiple dose part of the study, subjects will receive multiple doses of VNRX-5024 for 10 days.
Interventions
DRUGVNRX-5024
Part 1: one dose Part 2: Cohort 1: 10 doses (once a day for 10 days) Cohort 2: 19 doses (once every 12 hours \[q12h\] dosing for 9 days with a single morning dose on Day 10) Cohort 3: 28 doses (once every 8 hours \[q8h\] dosing for 9 days with a single morning dose on Day 10)
DRUGPlacebo for VNRX-5024
Part 1: one dose Part 2: Cohort 1: 10 doses (once a day for 10 days) Cohort 2: 19 doses (once every 12 hours \[q12h\] dosing for 9 days with a single morning dose on Day 10) Cohort 3: 28 doses (once every 8 hours \[q8h\] dosing for 9 days with a single morning dose on Day 10)
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Basilea Pharmaceutica
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adults 18-55 years 2. Males or non-pregnant, non-lactating females 3. Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2 4. Normal blood pressure 5. Normal lab tests
Exclusion criteria
1. Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder 2. History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug 3. Use of antacid medications 4. Abnormal ECG or history of clinically significant abnormal rhythm disorder 5. Positive alcohol, drug, or tobacco use/test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with adverse events | Day 19 |
Secondary
| Measure | Time frame |
|---|---|
| Part 2: AUC0-tau | Days 3-12 |
| Part 1: Cmax | Days 1-2 |
| Part 2: Cmax | Days 3-12 |
| Part 1: AUC0-tau | Days 1-2 |
| Part 2: tmax | Days 3-12 |
| Part 1: CLr | Days 1-2 |
| Part 2: CLr | Days 3-12 |
| Part 1: tmax | Days 1-2 |
Countries
Netherlands
Outcome results
None listed