drugset / Trial / NCT03981887

Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin

NCT03981887

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

EvaluationDrugModalityDoseRoute
Subject Nafithromycin Small molecule 200 mg Intravenous

Indications

No indication recorded.