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The primary objective is to determine the safety and tolerability of single and multiple ascending subcutaneous (SC) doses and a single intravenous (IV) dose of BIIB107 in healthy adult participants. The secondary objectives are to characterize the single-dose pharmacokinetic (PK) of SC and IV BIIB107 in healthy adult participants and to characterize the multiple-dose PK of SC BIIB107 in healthy adult participants.
BIIB107 is a monoclonal antibody (mAb) that targets alpha-4 integrins and is currently in development for people with multiple sclerosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1A | Experimental | Participants will receive Dose 1 of BIIB107 or placebo subcutaneous (SC) on Day 1. |
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| Cohort 2A | Experimental | Participants will receive Dose 2 of BIIB107 or placebo SC on Day 1. |
|
| Cohort 3A | Experimental | Participants will receive Dose 3 of BIIB107 or placebo SC on Day 1. |
|
| Cohort 4A | Experimental | Participants will receive Dose 4 of BIIB107 or placebo SC on Day 1. |
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| Cohort 7A | Experimental | Participants will receive Dose 5 of BIIB107 or placebo SC on Day 1. |
|
| Cohort 5A | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB107 | Drug | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs): Single Ascending Dose (SAD) | An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event. | Day -1 up to Day 84 |
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs): Multiple Ascending Dose (MAD) | An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event. | Day -1 up to Day 169 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUCinf): SAD | Day 1 pre-dose and multiple time-points up to Day 84 | |
| Maximum Observed Concentration (Cmax): SAD | Day 1 pre-dose and multiple time-points up to Day 84 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CenExel Anaheim Clinical Trials | Anaheim | California | 92801 | United States | ||
| QPS MRA (Miami Research Associates) |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Participants will receive Dose 5 of BIIB107 or placebo intravenous (IV) on Day 1.
|
| Cohort 8A | Experimental | Participants will receive Dose 6 of BIIB107 or placebo SC on Day 1. |
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| Cohort 1B | Experimental | Participants will receive multiple doses of BIIB107 or placebo SC on approximately 4 dosing days. |
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| Cohort 2B | Experimental | Participants will receive multiple doses of BIIB107 or placebo SC on approximately 4 dosing days. |
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| Placebo | Drug | Administered as specified in the treatment arm. |
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| Time to Reach Maximum Observed Concentration (Tmax): SAD | Day 1 pre-dose and multiple time-points up to Day 84 |
| Terminal Half-Life (t1/2): SAD | Day 1 pre-dose and multiple time-points up to Day 84 |
| Clearance (CL) for IV Doses: SAD | Day 1 pre-dose and multiple time-points up to Day 84 |
| Apparent Clearance (CL/F) of SC Doses: SAD | Day 1 pre-dose and multiple time-points up to Day 84 |
| Volume of Distribution at Steady State (Vss) for IV Doses: SAD | Day 1 pre-dose and multiple time-points up to Day 84 |
| Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) for SC Doses: SAD | Day 1 pre-dose and multiple time-points up to Day 84 |
| Bioavailability (F) of SC Doses: SAD | Day 1 pre-dose and multiple time-points up to Day 84 |
| Absorption Rate Profile of SC Doses: SAD | Day 1 pre-dose and multiple time-points up to Day 84 |
| Maximum Observed Concentration (Cmax): MAD | Day 1 pre-dose and multiple time-points up to Day 169 |
| Time to Reach Maximum Observed Concentration (Tmax): MAD | Day 1 pre-dose and multiple time-points up to Day 169 |
| Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau): MAD | Day 1 pre-dose and multiple time-points up to Day 169 |
| Trough Concentration (Ctrough): MAD | Day 1 pre-dose and multiple time-points up to Day 169 |
| Terminal Half-Life (t1/2): MAD | Day 1 pre-dose and multiple time-points up to Day 169 |
| Accumulation Ratio (R): MAD | Day 1 pre-dose and multiple time-points up to Day 169 |
| Apparent Clearance (CL/F) of SC Doses: MAD | Day 1 pre-dose and multiple time-points up to Day 169 |
| Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) for SC Doses: MAD | Day 1 pre-dose and multiple time-points up to Day 169 |
| Miami |
| Florida |
| 33143 |
| United States |
| Altasciences Clinical Research | Overland Park | Kansas | 66212 | United States |