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Also known as Other Names: BIIB092, BIIB092
BMS-986168 · 2 trials · 2 indications
To evaluate the safety and tolerability of a single intravenous (IV) infusion of BMS-986168 in healthy subjects.
| Arm | Type | Description |
|---|---|---|
| Panel 1: BIIB092/ Placebo | EXPERIMENTAL | BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks. |
| Panel 2: BIIB092/ Placebo | EXPERIMENTAL | BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks. |
| Panel 3: BIIB092/ Placebo | EXPERIMENTAL | BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks. |
| Panel 4: BIIB092/ Placebo | EXPERIMENTAL | BIIB092 or matching placebo administered by intravenous (IV) injection, up to a maximum of 3 doses once every four weeks. |
| 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 |
|---|---|---|
| BIIB092 | DRUG | See Arm Descriptions for dosing information. |
| Placebo | DRUG | See Arm Descriptions for dosing information. (0.9% Sodium Chloride for Injection or 5% Dextrose Injection if Sodium Chloride is not available) |
| BMS-986168 | DRUG | - |
| BMS-986168 Placebo | DRUG | - |
Inclusion Criteria 1. Probable or possible PSP defined as: * at least a 12-month history of postural instability or falls during the first 3 years that symptoms are present * a decreased downward saccade velocity at screening defined as observable eye movement deviation from the "main sequen...
BMS-986168 is an investigational small molecule being developed for the treatment of tauopathies, a group of neurodegenerative diseases characterized by abnormal tau protein accumulation. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
BMS-986168 is being developed by Biogen Inc. (NASDAQ: BIIB). The company is conducting clinical trials to evaluate the safety and tolerability of this investigational therapy for tauopathies.
BMS-986168 is in Phase 1 clinical development. A single ascending dose study in healthy subjects has been completed, but the drug remains investigational and has not received regulatory approval for any indication.
BMS-986168 has one completed Phase 1 trial, NCT02294851, a randomized, double-blind, placebo-controlled, single ascending dose study of intravenously administered BMS-986168 in healthy subjects. The trial enrolled 65 participants in the United States.
BMS-986168 is not FDA approved. It is an investigational drug in Phase 1 clinical development for tauopathies. The completed trial was a healthy volunteer study, and further clinical development would be required before any regulatory submission.