Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Biomedical Advanced Research and Development Authority | FED |
| Wellcome Trust | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single intravenous doses of MRX-8 | Active Comparator | Single escalating doses of MRX-8 |
|
| Single intravenous doses of placebo | Placebo Comparator | Single intravenous doses of placebo to match MRX-8 |
|
| Multiple intravenous doses of MRX-8 for 7 days | Active Comparator | Multiple ascending intravenous doses of MRX-8 every 12 hours for 7 days. |
|
| 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. |
|
| Multiple intravenous doses of MRX-8 for 14 days | Active Comparator | Multiple ascending intravenous doses of MRX-8 every 12 hours for 14 days. |
|
| Multiple intravenous doses of placebo for 14 days | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRX-8 | Drug | novel semi-synthetic polymyxin B analog. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Elimination of MRX-8 and its primary metabolite in urine | Quantity of measurable MRX-8 and its primary metabolite excreted in urine | At the end of infusion through 24 hours after the end of infusion on the final infusion of study drug |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Multiple intravenous doses of placebo every 12 hours for 14 days to match MRX-8. |
|
| Placebo | Drug | 5% dextrose in water |
|