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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-29

Study Completion Date

2021-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Single intravenous doses of MRX-8

Single escalating doses of MRX-8

Group Type ACTIVE_COMPARATOR

MRX-8

Intervention Type DRUG

novel semi-synthetic polymyxin B analog.

Single intravenous doses of placebo

Single intravenous doses of placebo to match MRX-8

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

5% dextrose in water

Multiple intravenous doses of MRX-8 for 7 days

Multiple ascending intravenous doses of MRX-8 every 12 hours for 7 days.

Group Type ACTIVE_COMPARATOR

MRX-8

Intervention Type DRUG

novel semi-synthetic polymyxin B analog.

Multiple intravenous doses of placebo for 7 days

Multiple intravenous doses of placebo every 12 hours for 7 days to match MRX-8.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

5% dextrose in water

Multiple intravenous doses of MRX-8 for 14 days

Multiple ascending intravenous doses of MRX-8 every 12 hours for 14 days.

Group Type ACTIVE_COMPARATOR

MRX-8

Intervention Type DRUG

novel semi-synthetic polymyxin B analog.

Multiple intravenous doses of placebo for 14 days

Multiple intravenous doses of placebo every 12 hours for 14 days to match MRX-8.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

5% dextrose in water

Interventions

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MRX-8

novel semi-synthetic polymyxin B analog.

Intervention Type DRUG

Placebo

5% dextrose in water

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes