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This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.
The LPS human endotoxemia model results in a well characterized, transient acute inflammatory response. The model has been widely used for decades as a system to study new therapeutic agents for inflammation before wider clinical studies are undertaken. This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TT301 | Experimental | Investigational drug TT301 |
|
| Placebo | Placebo Comparator | Normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TT301 | Drug | Single iv dose of TT301 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Cytokine levels post LPS challenge | Measured up to 12h post-LPS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Agensky, BSc, MBA | Transition Therapeutics Inc. / Waratah Pharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Clinical Research Unit | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Placebo |
| Drug |
Single iv dose of 0.9% sodium chloride for injection USP |
|
|
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D017670 |
| Sodium Compounds |