drugset / Trial / NCT04480333
Safety, Tolerability and Pharmacokinetics of Inhaled Nanoparticle Formulation of Remdesivir (GS-5734) and NA-831
RandomizedCrossoverTriple-blindTreatment
Summary
The clinical study is designed to evaluate the safety, tolerability and pharmacokinetics of inhaled nanoparticle nanoparticle formulation of Remdesivir (GS-5734) alone and in combination with NA-831 in 48 healthy volunteers.
Timeline
- Start
- 2020-09-15
- Primary completion
- 2020-12-31
- Completion
- 2021-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CYCLO(PROLYLGLYCYL) | Small molecule | 0.1 mg/kg | Inhaled |
| Subject | CYCLO(PROLYLGLYCYL) | Small molecule | 0.2 mg/kg | Inhaled |
| Subject | CYCLO(PROLYLGLYCYL) | Small molecule | 0.5 mg/kg | Inhaled |
| Subject | Remdesivir | Small molecule | 1 mg/kg | Inhaled |
| Subject | Remdesivir | Small molecule | 2 mg/kg | Inhaled |
| Subject | Remdesivir | Small molecule | 4 mg/kg | Inhaled |