Study of the Safety, Tolerability, and PK of MRX-8 Administered Intravenously to HVs in SAD and MAD Cohorts

MicuRx69 enrolled

Overview

This Phase 1 study is designed to assess the safety and tolerability of single and multiple intravenous (IV) doses of MRX-8, to assess the pharmacokinetics of MRX-8 and its primary metabolite following single and multiple IV doses, and to measure the elimination of MRX-8 and its metabolite in urine.

This is a first-in-human, randomized, double-blind, placebo-controlled study consisting of 3 parts. Part 1 will evaluate single ascending doses (SAD) of study drug. Part 2 will evaluate multiple ascending doses (MAD) of study drug administered for 7 days. Part 3 will evaluate MAD of study drug administered for 14 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Safety

Interventions

MRX-8DRUG

novel semi-synthetic polymyxin B analog.

PlaceboDRUG

5% dextrose in water

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Willing and able to provide written informed consent * In good general health Exclusion Criteria: * Prior participation in a study utilizing a polymyxin or aminoglycoside antibiotic or other nephrotoxic drug within the 12 months prior to study drug administration on Day 1 * Use of tobacco or nicotine products, in any form, within 30 days prior to study drug administration on Day 1 * Venous access considered inadequate for IV infusions, laboratory safety assessments, or PK sample collection * Underlying hepatic, renal, metabolic, cardiovascular or immunologic disorders

Locations (1)

Celerion

Tempe, Arizona, United States