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

An Adaptive, Randomized, Double Blind, Placebo Controlled Three Part Study of the Safety, Tolerability, and Pharmacokinetics of MRX-8 Administered Intravenously to Healthy Volunteers in Single Ascending and Multiple Ascending Dose Cohorts

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04649541

Enrollment

Registered

2020-12-02

Start date

2020-11-29

Completion date

2021-12-01

Last updated

2023-08-24

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

Conditions

Safety

Brief summary

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.

Detailed description

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.

Interventions

DRUGMRX-8

novel semi-synthetic polymyxin B analog.

DRUGPlacebo

5% dextrose in water

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

* 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

Design outcomes

Primary

Measure	Time frame	Description
Peak Plasma Concentration (Cmax)	Pre-dose through 48 hours after the end of infusion on the final infusion of study drug	Cmax of MRX-8 and its primary metabolite following single and multiple intravenous doses
Adverse events	Pre-dose through 48 hours after the end of infusion on the final infusion of study drug	Symptoms reported by subjects.
Clinical laboratory assessment	Pre-dose through 48 hours after the end of infusion on the final infusion of study drug	Complete blood count
Vital signs	Pre-dose through 48 hours after the end of infusion on the final infusion of study drug	Heart rate
Time to Peak Plasma Concentration (Tmax)	Pre-dose through 48 hours after the end of infusion on the final infusion of study drug	Tmax of MRX-8 and its primary metabolite following single and multiple intravenous doses
Area under the plasma concentration versus time curve (AUC)	Pre-dose through 48 hours after the end of infusion on the final infusion of study drug	AUC of MRX-8 and its primary metabolite following single and multiple intravenous doses

Secondary

Measure	Time frame	Description
Elimination of MRX-8 and its primary metabolite in urine	At the end of infusion through 24 hours after the end of infusion on the final infusion of study drug	Quantity of measurable MRX-8 and its primary metabolite excreted in urine

Countries

United States

Outcome results

None listed

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