drugset / Trial / NCT03981887
Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin
RandomizedParallel-groupQuadruple-blindBasic science
Summary
This will be a Phase 1, randomized, double-blind, single-center, placebo-controlled study in healthy male and female adult subjects. Subjects will be randomly assigned to receive either nafithromycin or placebo by intravenous (IV) infusion based on a double-blind randomization schedule. The following treatments will be administered: * Nafithromycin 200 mg or placebo administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days. * Eight subjects (n=8) will receive nafithromycin and 2 subjects (n=2) will receive placebo.
Timeline
- Start
- 2019-06-18
- Primary completion
- 2019-07-02
- Completion
- 2019-08-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nafithromycin | Small molecule | 200 mg | Intravenous |
Indications
No indication recorded.