NCT03033329

Single Dose Escalation and Multiple Dose Escalation Trial of an Intravenous Formulation of MRX-4

A Randomized, Double-Blind, Placebo Controlled Three-Part Study of the Safety, Tolerability, and Pharmacokinetics of MRX 4 Administered Intravenously to Healthy Volunteers in Single Ascending and Multiple Ascending Dose Cohorts, and Bioavailability of Oral MRX-4 Versus Intravenous Administration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: MicuRx · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Phase 1 study of the safety, tolerability, and pharmacokinetics of a new oxazolidinone antibiotic. In Part 1 cohorts of healthy adults will participate in a single dose escalation study of increasing intravenous doses of MRX-4. In Part 2 cohorts of healthy adults will participate in a multiple dose escalation study of increasing intravenous doses of MRX-4 given twice daily for ten days. Part 3 is a crossover study of oral MRX-4 versus a comparable intravenous dose of MRX-4 to determine bioavailability.

Conditions

• Safety

Interventions

Type	Name	Description
DRUG	Single intravenous doses of MRX-4	Intravenous single escalating doses of MRX-4
DRUG	Single intravenous doses of placebo	Intravenous single doses of placebo to match MRX-4
DRUG	Multiple intravenous doses of MRX-4	Multiple ascending doses of MRX-4 given intravenously twice daily for 10 days
DRUG	Multiple intravenous doses of placebo	Multiple doses of placebo to match MRX-4 given intravenously twice daily for 10 days
DRUG	Single dose of intravenous and oral MRX-4	Crossover single dose of intravenous and oral MRX-4 given on Day 1 and Day 4

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2017-01-26
• Last updated: 2018-03-22