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| ID | Type | Description | Link |
|---|---|---|---|
| HT9425-23-1-1064 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, first-in-human study to evaluate the safety of an investigational drug to treat burns. Participants will be healthy male and female adults. The study will consist of a screening period, inpatient dosing and observation period and safety follow-up. Participants will receive 1 intravenous dose of the investigational drug or placebo. Duration of participation will be approximately 38 days, which includes a maximum of a 30 day screening period and a study period of approximately 8 days.
Up to 32 healthy, male and female subjects will be enrolled in this Phase 1, single-center, randomized, double-blind, placebo-controlled, first-in-human study. Eligible subjects will be confined to a Phase 1 unit for approximately 48 hours and receive a one time IV dose of study medication. They will be required to return for a safety follow-up visit one week later.
Doses will be studied sequentially starting with the lowest dose of the investigational drug, cNP8. Each dose cohort will include a total of 6 subjects dosed with cNP8 and 2 subjects dosed with placebo.
A sentinel dosing plan with staggered enrollment will be employed. For each dosing cohort, 2 subjects will be dosed (1 with cNP8 and 1 with placebo) and monitored for serious and/or severe adverse events (AEs). If no serious or severe AEs occur in 24 hours postdose, the remaining 6 subjects in the cohort will be dosed.
Safety evaluations, including laboratory tests, vital sign measurements and electrocardiograms, will be performed at several timepoints throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single ascending doses of cNP8 | Experimental | Subjects will be randomized to receive either a single dose of cNP8 or placebo (6:2). The doses will be studied sequentially starting with the lowest cNP8 dose. |
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| Single doses of placebo administered | Placebo Comparator | Subjects will be randomized to receive either a single dose of cNP8 or placebo (6:2). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cNP8 | Drug | cNP8 for injection is provided as a sterile lyophilizate for solution for infusion. Subjects will receive a single 30 minute IV infusion of cNP8 at their assigned dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events from dosing through follow-up | Clinical safety laboratory data will be collected | Day -1, Day 2, Day 8 Safety Follow-up |
| Incidence and severity of adverse events from dosing through follow-up | Electrocardiograms will be performed | Day -1, 1 hour postdose, 6 hours postdose, Day 2 and Day 8 Safety Follow-up |
| Incidence and severity of adverse events from dosing through follow-up | Vital signs | Predose, 0.25,0.50, 0.75,1,1.5, 2,4,6,12 hours postdose, Day 2 and Day 8 Safety Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile | Cmax | Predose, 0.25,0.50,0.75,1,1.5, 2,4,6,12 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Saint Paul | Minnesota | 55114 | United States |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Placebo | Other | Subjects not randomized to cNP8 will receive a single 30 minute IV infusion of placebo. |
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