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

Safety Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04649541
• Other study ID #: MRX8-101
• Status: Completed
• Phase: Phase 1
• Start date: November 29, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: August 2023
• Source: MicuRx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Safety

Intervention

Drug:
• MRX-8
novel semi-synthetic polymyxin B analog.
• Placebo
5% dextrose in water

Locations

Country	Name	City	State
United States	Celerion	Tempe	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
MicuRx	Biomedical Advanced Research and Development Authority, Wellcome Trust

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Symptoms reported by subjects.	Pre-dose through 48 hours after the end of infusion on the final infusion of study drug
Primary	Clinical laboratory assessment	Complete blood count	Pre-dose through 48 hours after the end of infusion on the final infusion of study drug
Primary	Peak Plasma Concentration (Cmax)	Cmax of MRX-8 and its primary metabolite following single and multiple intravenous doses	Pre-dose through 48 hours after the end of infusion on the final infusion of study drug
Primary	Time to Peak Plasma Concentration (Tmax)	Tmax of MRX-8 and its primary metabolite following single and multiple intravenous doses	Pre-dose through 48 hours after the end of infusion on the final infusion of study drug
Primary	Area under the plasma concentration versus time curve (AUC)	AUC of MRX-8 and its primary metabolite following single and multiple intravenous doses	Pre-dose through 48 hours after the end of infusion on the final infusion of study drug
Primary	Vital signs	Heart rate	Pre-dose through 48 hours after the end of infusion on the final infusion of study drug
Secondary	Elimination of MRX-8 and its primary metabolite in urine	Quantity of measurable MRX-8 and its primary metabolite excreted in urine	At the end of infusion through 24 hours after the end of infusion on the final infusion of study drug