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

NCT03033329 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2018-03-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • MicuRx

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-03-31
Completion
2018-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03033329 on ClinicalTrials.gov