Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03976349 | A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease | PHASE1 | COMPLETED | 62 | — | — | Aug 12, 2019 | Aug 12, 2024 | Sep 23, 2025 | 18 | United States, Canada +4 |
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is a medically important event.
| Arm | Type | Description |
|---|---|---|
| Part A (SAD): BIIB094 Dose 1 | EXPERIMENTAL | Participants will receive a single IT injection of BIIB094 during Part A \[Single Ascending Dose (SAD)\]. |
| Part A (SAD): BIIB094 Dose 2 | EXPERIMENTAL | Participants will receive a single IT injection of BIIB094 during Part A (SAD). |
| Part A (SAD): BIIB094 Dose 3 | EXPERIMENTAL | Participants will receive a single IT injection of BIIB094 during Part A (SAD). |
| Part A (SAD): BIIB094 Dose 4 | EXPERIMENTAL | Participants will receive a single IT injection of BIIB094 during Part A (SAD). |
| Part A (SAD): BIIB094 Dose 5 | EXPERIMENTAL | Participants will receive a single IT injection of BIIB094 during Part A (SAD). |
| Part A (SAD): BIIB094 Dose 6 | EXPERIMENTAL | Participants will receive a single IT injection of BIIB094 during Part A (SAD). |
| Part B (MAD): BIIB094 Dose 1 | EXPERIMENTAL | Participants will receive a single IT injection of BIIB094 on multiple days during Part B \[Multiple Ascending Dose (MAD)\]. |
| Part B (MAD): BIIB094 (Non LRRK2) Dose 2 | EXPERIMENTAL | Participants \[Non leucine-rich repeat kinase 2 (Non LRRK2)\] will receive a single IT injection of BIIB094 on multiple days during Part B (MAD). |
| Part B (MAD): BIIB094 (LRRK2) Dose 2 | EXPERIMENTAL | Participants (LRRK2) will receive a single IT injection of BIIB094 on multiple days during Part B (MAD). |
| Part B (MAD): BIIB094 (Non LRRK2) Dose 3 | EXPERIMENTAL | Participants (Non LRRK2) will receive a single IT injection of BIIB094 on multiple days during Part B (MAD). |
| Part B (MAD): BIIB094 (LRRK2) Dose 3 | EXPERIMENTAL | Participants (LRRK2) will receive a single IT injection of BIIB094 on multiple days during Part B (MAD). |
| Part A (SAD): Matching Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo during Part A \[Single Ascending Dose (SAD)\]. |
| Part B (MAD): Matching Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo on multiple days during Part B (MAD). |
| Name | Type | Description |
|---|---|---|
| BIIB094 | DRUG | Administered as specified in the treatment arm. |
| Placebo | DRUG | Administered as specified in the treatment arm. |
Key Inclusion Criteria: * Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local participant privacy regulations. * Diagnosed with PD within 7 years at the ...