Clinical trial NCT04649541: Study of the Safety, Tolerability, and PK of MRX-8 Administered Intravenously to HVs in SAD and MAD Cohorts
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety
Lead sponsor: MicuRx
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
name: Wellcome Trust
First posted: 2020-12-02
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adverse events
timeFrame: Pre-dose through 48 hours after the end of infusion on the final infusion of study drug
measure: Clinical laboratory assessment
timeFrame: Pre-dose through 48 hours after the end of infusion on the final infusion of study drug
measure: Peak Plasma Concentration (Cmax)
timeFrame: Pre-dose through 48 hours after the end of infusion on the final infusion of study drug
measure: Time to Peak Plasma Concentration (Tmax)
timeFrame: Pre-dose through 48 hours after the end of infusion on the final infusion of study drug
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: Pre-dose through 48 hours after the end of infusion on the final infusion of study drug
measure: Vital signs
timeFrame: Pre-dose through 48 hours after the end of infusion on the final infusion of study drug
Secondary outcomes:
measure: Elimination of MRX-8 and its primary metabolite in urine
timeFrame: At the end of infusion through 24 hours after the end of infusion on the final infusion of study drug
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
References: