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

Completed · Phase 1 · Has a placebo group

Conditions studied: Safety

In brief

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.

Key facts

Study ID

NCT04649541

Run by

MicuRx

People needed

69

Starts

2020-11-29

Expected to finish

2021-12-01

Last updated by the study team

2023-08-24

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Willing and able to provide written informed consent
• In good general health

You may not qualify if…

• 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

Where it is running

• Celerion — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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