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

NCT03033329 Phase 1 COMPLETED

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.

Details

Lead sponsor	MicuRx
Phase	Phase 1
Status	COMPLETED
Enrolment	90
Start date	2016-10
Completion	2018-03

Conditions

• Safety

Interventions

• Single intravenous doses of MRX-4
• Single intravenous doses of placebo
• Multiple intravenous doses of MRX-4
• Multiple intravenous doses of placebo
• Single dose of intravenous and oral MRX-4

Primary outcomes

• Safety of single and multiple ascending doses of MRX-4 — Screening through end of study visit on Day 7 (Part 1), Day 17 (Part II) and Day 15 (Part III)
  Summary statistics of the number of subjects with changes in vital signs, physical examinations, clinical lab data, ecg parameters, and adverse events