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drugset / Trial / NCT03033329

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

NCT03033329 ↗

Phase 1 Completed 90 enrolled MicuRx Worldwide Clinical Trials · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2016-10
Primary completion
2018-03
Completion
2018-03

Drugs

EvaluationDrugModalityDoseRoute
Subject MRX-4 Small molecule 150 mg Intravenous
Subject MRX-4 Small molecule 600 mg Intravenous
Subject MRX-4 Small molecule 900 mg Intravenous
Subject MRX-4 Small molecule 1200 mg Intravenous
Subject MRX-4 Small molecule 1500 mg Intravenous
Subject MRX-4 Small molecule 1800 mg Intravenous

Indications

No indication recorded.