NCT03981887

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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Wockhardt · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Nafithromycin	Nafithromycin 200 mg as IV infusion
OTHER	Placebo	placebo administered as IV infusion

Timeline

• Start date: 2019-06-18
• Primary completion: 2019-07-02
• Completion: 2019-08-07
• First posted: 2019-06-11
• Last updated: 2019-10-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study