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This is a randomized, double-blind, placebo controlled, single ascending dose escalation, safety, tolerability, PK, PD and immunogenicity study of BMS-986168 administered by an intravenous infusion in healthy subjects.
This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a licensing agreement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending dose cohorts | Experimental | Single ascending dose escalation, safety, tolerability, PK, PD and immunogenicity study of BMS-986168 administered by an intravenous infusion in healthy subjects. |
|
| Placebo | Placebo Comparator | BMS-986168 Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986168 | Drug |
|
| |
| BMS-986168 Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability, as measured by incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, and physical and neurological examinations. | To evaluate the safety and tolerability of a single intravenous (IV) infusion of BMS-986168 in healthy subjects. | 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WCCT Global, LLC | Cypress | California | 90630 | United States | ||
| Covance Clinical Research Unit Inc. |
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| ID | Term |
|---|---|
| D024801 | Tauopathies |
| ID | Term |
|---|---|
| D019636 | Neurodegenerative Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000707052 | gosuranemab |
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| Drug |
|
| Dallas |
| Texas |
| 75247 |
| United States |