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

NCT04649541 | Completed Phase 1 FDA Drug

• 1 other identifier: MRX8-101
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Safety

Outcome Measures

Primary Outcomes (6)

• Adverse events

  Symptoms reported by subjects.

  Pre-dose through 48 hours after the end of infusion on the final infusion of study drug

• Clinical laboratory assessment

  Complete blood count

  Pre-dose through 48 hours after the end of infusion on the final infusion of study drug

• Peak Plasma Concentration (Cmax)

  Cmax of MRX-8 and its primary metabolite following single and multiple intravenous doses

  Pre-dose through 48 hours after the end of infusion on the final infusion of study drug

• Time to Peak Plasma Concentration (Tmax)

  Tmax of MRX-8 and its primary metabolite following single and multiple intravenous doses

  Pre-dose through 48 hours after the end of infusion on the final infusion of study drug

• Area under the plasma concentration versus time curve (AUC)

  AUC of MRX-8 and its primary metabolite following single and multiple intravenous doses

  Pre-dose through 48 hours after the end of infusion on the final infusion of study drug

• Vital signs

  Heart rate

  Pre-dose through 48 hours after the end of infusion on the final infusion of study drug

Secondary Outcomes (1)

• 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

Study Arms (6)

Single intravenous doses of MRX-8

ACTIVE COMPARATOR

Single escalating doses of MRX-8

Drug: MRX-8

Single intravenous doses of placebo

PLACEBO COMPARATOR

Single intravenous doses of placebo to match MRX-8

Drug: Placebo

Multiple intravenous doses of MRX-8 for 7 days

ACTIVE COMPARATOR

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

Drug: MRX-8

Multiple intravenous doses of placebo for 7 days

PLACEBO COMPARATOR

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

Drug: Placebo

Multiple intravenous doses of MRX-8 for 14 days

ACTIVE COMPARATOR

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

Drug: MRX-8

Multiple intravenous doses of placebo for 14 days

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

MRX-8 DRUG

novel semi-synthetic polymyxin B analog.

Multiple intravenous doses of MRX-8 for 14 days; Multiple intravenous doses of MRX-8 for 7 days; Single intravenous doses of MRX-8

Placebo DRUG

5% dextrose in water

Multiple intravenous doses of placebo for 14 days; Multiple intravenous doses of placebo for 7 days; Single intravenous doses of placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• MicuRx: lead
• Biomedical Advanced Research and Development Authority: collaborator
• Wellcome Trust: collaborator

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: December 2, 2020
• Study Start: November 29, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)