Study of the Safety, Tolerability, and PK of MRX-8 Administered Intravenously to HVs in SAD and MAD Cohorts
- Registration Number
- NCT04649541
- Lead Sponsor
- MicuRx
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
- Willing and able to provide written informed consent
- In good general health
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single intravenous doses of MRX-8 MRX-8 Single escalating doses of MRX-8 Single intravenous doses of placebo Placebo Single intravenous doses of placebo to match MRX-8 Multiple intravenous doses of placebo for 14 days Placebo Multiple intravenous doses of placebo every 12 hours for 14 days to match MRX-8. Multiple intravenous doses of MRX-8 for 7 days MRX-8 Multiple ascending intravenous doses of MRX-8 every 12 hours for 7 days. Multiple intravenous doses of placebo for 7 days Placebo Multiple intravenous doses of placebo every 12 hours for 7 days to match MRX-8. Multiple intravenous doses of MRX-8 for 14 days MRX-8 Multiple ascending intravenous doses of MRX-8 every 12 hours for 14 days.
- Primary Outcome Measures
Name Time Method 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
Vital signs Pre-dose through 48 hours after the end of infusion on the final infusion of study drug Heart rate
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
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
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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Celerion
🇺🇸Tempe, Arizona, United States