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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03033329

Enrollment

Registered

2017-01-26

Start date

2016-10-31

Completion date

2018-03-31

Last updated

2018-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety

Brief 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.

Interventions

DRUGSingle intravenous doses of MRX-4

Intravenous single escalating doses of MRX-4

DRUGSingle intravenous doses of placebo

Intravenous single doses of placebo to match MRX-4

DRUGMultiple intravenous doses of MRX-4

Multiple ascending doses of MRX-4 given intravenously twice daily for 10 days

DRUGMultiple intravenous doses of placebo

Multiple doses of placebo to match MRX-4 given intravenously twice daily for 10 days

DRUGSingle dose of intravenous and oral MRX-4

Crossover single dose of intravenous and oral MRX-4 given on Day 1 and Day 4

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy subjects

Exclusion criteria

* Underlying hepatic, renal, metabolic, hematologic, cardiovascular, or immunologic disorder

Design outcomes

Primary

Measure	Time frame	Description
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

Secondary

Measure	Time frame	Description
Plasma concentration time data for MRX-4 and its metabolites	Pre-dose through 72 hours post dose	Individual and mean plasma concentration time data for MRX-4 and its metabolites
Bioavailability of MRX-I and other MRX-4 metabolites	Pre-dose through 72 hours post dose	Levels of MRX-4 and its metabolites in blood
Comparison of the pharmacokinetics of oral versus intravenous MRX-4 and its metabolites	Pre-dose through 72 hours post dose	Levels of MRX-4 and its metabolites in blood
Elimination of MRX-4 and its metabolites in the urine following single dose adminstration	Pre-dose through 72 hours post dose	Levels of MRX-4 and its metabolites in urine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026