NCT04649541

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: MicuRx · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Safety

Interventions

Type	Name	Description
DRUG	MRX-8	novel semi-synthetic polymyxin B analog.
DRUG	Placebo	5% dextrose in water

Timeline

• Start date: 2020-11-29
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2020-12-02
• Last updated: 2023-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study