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Completed

NCT Number: NCT04649541

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

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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Key information

Conditions

Safety

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Tempe, Arizona, 85283, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRX-8

Drug

novel semi-synthetic polymyxin B analog.

Placebo

Drug

5% dextrose in water

Primary outcomes

  1. Adverse events

    Time frame: Pre-dose through 48 hours after the end of infusion on the final infusion of study drug

    Symptoms reported by subjects.

  2. Clinical laboratory assessment

    Time frame: Pre-dose through 48 hours after the end of infusion on the final infusion of study drug

    Complete blood count

  3. Peak Plasma Concentration (Cmax)

    Time frame: 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

  4. Time to Peak Plasma Concentration (Tmax)

    Time frame: 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

  5. Area under the plasma concentration versus time curve (AUC)

    Time frame: 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

  6. Vital signs

    Time frame: Pre-dose through 48 hours after the end of infusion on the final infusion of study drug

    Heart rate

Secondary outcomes

  1. Elimination of MRX-8 and its primary metabolite in urine

    Time frame: 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

Sponsors and collaborators

Lead sponsor

MicuRx

Industry

Collaborators

  • Biomedical Advanced Research and Development Authority
  • Wellcome Trust

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 2, 2020
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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