SafetyPhase 1NCT04649541
Study of the Safety, Tolerability, and PK of MRX-8 Administered Intravenously to HVs in SAD and MAD Cohorts
A Phase 1 study testing MRX-8 in people with Safety, run by MicuRx at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety
- What is being tested?
- MRX-8
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2020to 1 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to provide written informed consent
- In good general health
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Safety
- Being tested
- MRX-8, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRX-8Drug
novel semi-synthetic polymyxin B analog.
PlaceboDrug
5% dextrose in water
| Study group | Role | What they receive |
|---|---|---|
| Single intravenous doses of MRX-8 | Active comparator | Single escalating doses of MRX-8 Receives: Drug: MRX-8 |
| Single intravenous doses of placebo | Placebo comparator | Single intravenous doses of placebo to match MRX-8 Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Symptoms reported by subjects.
Measured: Pre-dose through 48 hours after the end of infusion on the final infusion of study drug
Clinical laboratory assessment
Complete blood count
Measured: 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
Measured: 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
Measured: 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
Measured: Pre-dose through 48 hours after the end of infusion on the final infusion of study drug
Vital signs
Heart rate
Measured: 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
Quantity of measurable MRX-8 and its primary metabolite excreted in urine
Measured: At the end of infusion through 24 hours after the end of infusion on the final infusion of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start29 Nov 2020
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicuRx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority, Wellcome Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649541
- Sponsor's protocol ID
- MRX8-101
- Status last verified
- Aug 2023
- First submitted
- 16 Nov 2020
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04649541
- Acronym / sponsor ID
- MRX8-101
- Conditions
- Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- MicuRxIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority, Wellcome Trust
- Study start
- 29 Nov 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Single intravenous doses of MRX-8 | Active comparator | Drug: MRX-8Single escalating doses of MRX-8 |
| Single intravenous doses of placebo | Placebo comparator | Drug: PlaceboSingle intravenous doses of placebo to match MRX-8 |
| Multiple intravenous doses of MRX-8 for 7 days | Active comparator | Drug: MRX-8Multiple ascending intravenous doses of MRX-8 every 12 hours for 7 days. |
| Multiple intravenous doses of placebo for 7 days | Placebo comparator | Drug: PlaceboMultiple intravenous doses of placebo every 12 hours for 7 days to match MRX-8. |
| Multiple intravenous doses of MRX-8 for 14 days | Active comparator | Drug: MRX-8Multiple ascending intravenous doses of MRX-8 every 12 hours for 14 days. |
| Multiple intravenous doses of placebo for 14 days | Placebo comparator | Drug: PlaceboMultiple intravenous doses of placebo every 12 hours for 14 days to match MRX-8. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Willing and able to provide written informed consent
- In good general health
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRX-8novel semi-synthetic polymyxin B analog. | Drug | Multiple intravenous doses of MRX-8 for 14 days, Multiple intravenous doses of MRX-8 for 7 days, Single intravenous doses of MRX-8 |
| Placebo5% dextrose in water | Drug | Multiple intravenous doses of placebo for 14 days, Multiple intravenous doses of placebo for 7 days, Single intravenous doses of placebo |
Primary outcome
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.
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
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
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
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
Vital signs
Time frame: Pre-dose through 48 hours after the end of infusion on the final infusion of study drug
Heart rate
1 secondary outcome
Elimination of MRX-8 and its primary metabolite in urine
Time frame: At the end of infusion through 24 hours after the end of infusion on the final infusion of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MRX-8 in people with Safety, run by MicuRx at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Pre-dose through 48 hours after the end of infusion on the final infusion of study drug). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.