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
Overview
- Phase
- Phase 1
- Intervention
- MRX-8
- Conditions
- Safety
- Sponsor
- MicuRx
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- Time to Peak Plasma Concentration (Tmax)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Single intravenous doses of MRX-8
Single escalating doses of MRX-8
Intervention: MRX-8
Single intravenous doses of placebo
Single intravenous doses of placebo to match MRX-8
Intervention: Placebo
Multiple intravenous doses of MRX-8 for 7 days
Multiple ascending intravenous doses of MRX-8 every 12 hours for 7 days.
Intervention: MRX-8
Multiple intravenous doses of placebo for 7 days
Multiple intravenous doses of placebo every 12 hours for 7 days to match MRX-8.
Intervention: Placebo
Multiple intravenous doses of MRX-8 for 14 days
Multiple ascending intravenous doses of MRX-8 every 12 hours for 14 days.
Intervention: MRX-8
Multiple intravenous doses of placebo for 14 days
Multiple intravenous doses of placebo every 12 hours for 14 days to match MRX-8.
Intervention: Placebo
Outcomes
Primary Outcomes
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
Vital signs
Time Frame: Pre-dose through 48 hours after the end of infusion on the final infusion of study drug
Heart rate
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
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
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
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.
Secondary Outcomes
- 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)