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| ID | Type | Description | Link |
|---|---|---|---|
| S-12-08/A-15399.2 | Other Identifier | USAMRMC |
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This clinical study will evaluate escalating dosages of MMB4 DMS to determine its safety when delivered intramuscularly (i.m.) to the anterior thigh.
The goal of this study is to assess safety, tolerability, and PK of MMB4 DMS EF at up to six cohorts chosen to provide the range required for PK analyses, including assessment of dose proportionality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.6 mg/kg MMB4 DMS | Experimental | 0.6 mg/kg 1,1'-Methylenebis[4-[(hydroxyimino) methyl]-pyridinium] dimethanesulfonate (MMB4 DMS), intramuscular (i.m.) to the anterior thigh. |
|
| Placebo | Placebo Comparator | filtered cottonseed oil for injection. Three and a half milliliter aliquots of the placebo are placed in each 5-mL vial and administered intramuscular (i.m.) to the anterior thigh. |
|
| 0.9 mg/kg MMB4 DMS | Experimental | 0.9 mg/kg 1,1'-Methylenebis[4-[(hydroxyimino) methyl]-pyridinium] dimethanesulfonate (MMB4 DMS), intramuscular (i.m.) to the anterior thigh. |
|
| 1.2 mg/kg MMB4 DMS | Experimental | 1.2 mg/kg 1,1'-Methylenebis[4-[(hydroxyimino) methyl]-pyridinium] dimethanesulfonate (MMB4 DMS), intramuscular (i.m.) to the anterior thigh. |
|
| 1.5 mg/kg MMB4 DMS | Experimental | 1.5 mg/kg 1,1'-Methylenebis[4-[(hydroxyimino) methyl]-pyridinium] dimethanesulfonate (MMB4 DMS), intramuscular (i.m.) to the anterior thigh. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MMB4 DMS | Drug | Subjects will be administered the drug product formulation at the assigned dosage of MMB4 DMS or placebo i.m. to the anterior thigh using a 5 mL syringe. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events (AE) | 30 days post-administration |
| Measure | Description | Time Frame |
|---|---|---|
| Safety electrocardiogram (ECG) (3-5 lead) | Up to 48-hours post administration | |
| Oxygen saturation | Up to 48-hours post administration | |
| End-Tidal carbon dioxide |
| Measure | Description | Time Frame |
|---|---|---|
| Observed Cmax | Samples will be analyzed for MMB4 using a validated high performance liquid chromatography-tandem mass spectrometry (HPLC/MS/MS) | Multiple timepoints between 0 and 24 hours |
| Observed Tmax |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed S Al-Ibrahim, MD | SNBL Clinical Pharmacology Center, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SNBL Clinical Pharmacology Center, Inc. | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| C005514 | N,N'-monomethylenebis(pyridiniumaldoxime) |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Subjects will be administered the drug product formulation at the assigned dosage of placebo i.m. to the anterior thigh using a 5 mL syringe. The placebo group in each cohort will receive the same injection volume and number of injections as the dose group in that cohort. |
|
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| Up to 48 hours post administration |
| Blood pressure | Up to 48 hours post administration |
Samples will be analyzed for MMB4 using a validated high performance liquid chromatography-tandem mass spectrometry (HPLC/MS/MS). Samples will be evaluated using semi-log plots and characterized using non-compartmental analysis.
| Multiple timepoints between 0 and 24 hours |