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

MicuRx

Status and phase: Completed; Phase 1

Conditions: Safety

Treatments: Drug: Multiple intravenous doses of placebo; Drug: Multiple intravenous doses of MRX-4; Drug: Single intravenous doses of placebo; Drug: Single dose of intravenous and oral MRX-4; Drug: Single intravenous doses of MRX-4

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03033329

MRX4-002

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 5 patient groups, including a placebo group

Single intravenous doses of MRX-4

Experimental group

Description:

Single escalating intravenous doses of MRX-4 from 150 mg to 1800 mg

Treatment:

Drug: Single intravenous doses of MRX-4

Single intravenous doses of placebo

Placebo Comparator group

Description:

Single intravenous doses of placebo to match MRX-4

Treatment:

Drug: Single intravenous doses of placebo

Multiple intravenous doses of MRX-4

Active Comparator group

Description:

Twice daily escalating intravenous doses of MRX-4 for 10 days: 600 mg, 900 mg, 1200 mg, and 1500 mg

Treatment:

Drug: Multiple intravenous doses of MRX-4

Multiple intravenous doses of placebo

Placebo Comparator group

Description:

Twice daily intravenous doses of placebo to match MRX-4 for 10 days

Treatment:

Drug: Multiple intravenous doses of placebo

Single dose of intravenous and oral MRX-4

Active Comparator group

Description:

Crossover of single dose of intravenous and oral MRX-4

Treatment:

Drug: Single dose of intravenous and oral MRX-4