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| Name | Class |
|---|---|
| PRA Health Sciences | INDUSTRY |
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This is a Phase I, multi-center, double-blind, randomized, placebo-controlled, dose-escalation study designed to evaluate safety, tolerability, pharmacokinetics, and immunogenicity of single intravenous (IV) administrations of rHIgM22 in patients with all clinical presentations of MS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rHIgM22 | Placebo Comparator | Cohorts 1-5: In each dosing cohort, the first 2 eligible patients will be enrolled and randomized 1:1 to receive rHIgM22 or placebo, and monitored for safety for a minimum of 7 days before the remaining 8 patients in the cohort are randomized (7 active: 1 placebo) and dosed. Expanded Cohort: Upon establishment of a Maximally Tolerated Dose (MTD), a new group of 21 patients will be enrolled in an Expansion Cohort. Randomly assigned in a 1:1:1 ratio to 1 of 3 treatment groups: placebo, Investigational Product (IP) at MTD, or IP at one full dose level lower than MTD. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rHIgM22 | Drug | Administered via IV infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of single ascending doses of the human monoclonal rHIgM22 in patients with MS. | Monitoring of adverse events (AEs) will be conducted throughout the study. Adverse events, including serious adverse events will be recorded in the case report forms (CRFs). | 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Measure the pharmacokinetics (PK) of single ascending doses of rHIgM22 | PK parameters will include; The maximum measured plasma concentration (Cmax), time to maximum plasma concentration (Tmax), half-life (T1/2), and the area under the concentration curve from time 0 to the concentration at last time point (AUC (0-last)). | Day 1 through Day 180 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enrique Carrazana, MD | Acorda Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acorda Investigational Site | Long Beach | California | 90806 | United States | ||
| Acorda Investigational Site |
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| Measure the pharmacodynamics of single ascending doses of rHIgM22 using the Expanded Disability Status Scale (EDSS) | Day 1 through Day 180 |
| Palo Alto |
| California |
| 04158 |
| United States |
| Acorda Investigational Site | Sacramento | California | 95817 | United States |
| Acorda Investigational Site | Stanford | California | 94305-5235 | United States |
| Acorda Investigational Site | Aurora | Colorado | 80045 | United States |
| Acorda Investigational Site | Centennial | Colorado | 80112 | United States |
| Acorda Investigational Site | Indianapolis | Indiana | 46202 | United States |
| Acorda Investigational Site | Kansas City | Kansas | 66160 | United States |
| Acorda Investigational Site | Baltimore | Maryland | 22125 | United States |
| Acorda Investigational Site | St Louis | Missouri | 63131 | United States |
| Acorda Investigational Site | Rochester | New York | 14642 | United States |
| Acorda Investigational Site | Providence | Rhode Island | 02905 | United States |
| Acorda Investigational Site | Knoxville | Tennessee | 37920 | United States |
| Acorda Investigational Site | Dallas | Texas | 75390-9036 | United States |
| Acorda Investigational Site | Burlington | Vermont | 05401 | United States |
| Acorda Investigational Site | Seattle | Washington | 98101 | United States |
| Acorda Investigational Site | Seattle | Washington | 98122 | United States |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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