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The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in combination with rabies vaccine compared with human rabies immune globulin (HRIG) or placebo in combination with rabies vaccine in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | CL184 combined with rabies vaccination |
|
| B | Active Comparator | HRIG combined with rabies vaccination |
|
| C | Placebo Comparator | Placebo combined with rabies vaccination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CL184 | Biological | CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rabies virus neutralizing activity | 42 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| C. James Kissling, MD | MDS Pharma Services, 621 Rose Street, Lincoln, NE 68502, USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MDS Pharma Services , USA | Lincoln | Nebraska | 68502 | United States |
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| HRIG | Biological | HRIG 20 IU/kg intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28 |
|
| Placebo matching CL184 | Biological | Placebo intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28 |
|
| ID | Term |
|---|---|
| D011818 | Rabies |
| ID | Term |
|---|---|
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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