Healthy Volunteers
Conditions
Keywords
VNRX-7145, Safety, Pharmacokinetics
Brief summary
This is a 2-part, first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-7145. In part 1, subjects will receive a single dose of VNRX-7145; in part 2 subjects will receive multiple doses of VNRX-7145 for 10 days.
Interventions
DRUGVNRX-7145
Part 1: one dose Part 2: 28 doses (once every 8 hour \[q8h\] dosing for 9 days with a single morning dose on Day 10)
DRUGPlacebo
Part 1: one dose Part 2: 28 doses (once every 8 hour \[q8h\] 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
SINGLE_GROUP
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 18-45 years * Males or non-pregnant, non-lactating females * Body mass index (BMI): ≥18.5 kg/m² and ≤32.0 kg/m² * Normal blood pressure * Normal laboratory tests
Exclusion criteria
* Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder * History of drug allergy * Abnormal ECG or history of clinically significant abnormal rhythm disorder * Positive alcohol, drug, or tobacco use/test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Number of subjects with adverse events | Day 8 |
| Part 2: Number of subjects with adverse events | Day 17 |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: tmax | Days 1-3 |
| Part 1: CLr | Days 1-3 |
| Part 2: AUC0-tau | Days 1-10 |
| Part 1: AUC0-tau | Days 1-3 |
| Part 2: tmax | Days 1-10 |
| Part 2: CLr | Days 1-10 |
| Part 2: Cmax | Days 1-10 |
| Part 1: Cmax | Days 1-3 |
Countries
United States
Outcome results
None listed