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

MicuRx

Status and phase: Completed; Phase 1

Conditions: Safety

Treatments: Drug: Placebo; Drug: MRX-8

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT04649541

MRX8-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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69 participants in 6 patient groups, including a placebo group

Single intravenous doses of MRX-8

Active Comparator group

Description:

Single escalating doses of MRX-8

Treatment:

Drug: MRX-8

Single intravenous doses of placebo

Placebo Comparator group

Description:

Single intravenous doses of placebo to match MRX-8

Treatment:

Drug: Placebo

Multiple intravenous doses of MRX-8 for 7 days

Active Comparator group

Description:

Multiple ascending intravenous doses of MRX-8 every 12 hours for 7 days.

Treatment:

Drug: MRX-8

Multiple intravenous doses of placebo for 7 days

Placebo Comparator group

Description:

Multiple intravenous doses of placebo every 12 hours for 7 days to match MRX-8.

Treatment:

Drug: Placebo

Multiple intravenous doses of MRX-8 for 14 days

Active Comparator group

Description:

Multiple ascending intravenous doses of MRX-8 every 12 hours for 14 days.

Treatment:

Drug: MRX-8

Multiple intravenous doses of placebo for 14 days

Placebo Comparator group

Description:

Multiple intravenous doses of placebo every 12 hours for 14 days to match MRX-8.

Treatment:

Drug: Placebo