Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this study, researchers will learn how the body processes a study drug called BIIB144. This is a "first-in-human" study. This means that this study drug will be given to people for the first very time in this study. These studies are important because they help researchers learn about the safety of the study drug, how the body processes it, and what dose might be appropriate before testing it in larger groups.
The main goal of this study is to learn more about the safety of a single dose of BIIB144 compared to a placebo. A placebo is something that looks like the study drug but does not contain any medicine. A placebo is also given in the same way as the study drug.
The main question researchers want to answer in this study is:
How many participants have adverse events (AEs) and serious adverse events (SAEs)? An AE is a health problem that may or may not be caused by the study drug.
Researchers will also learn more about:
This study will be done as follows:
The primary objective of this study is to evaluate the safety and tolerability of IV administered ascending single doses of BIIB144 compared with placebo in healthy adult participants. The secondary objective is to characterize the pharmacokinetics (PK) of IV administered ascending single doses of BIIB144 in healthy adult participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIB144 Cohort 1 | Experimental | Participants will receive Dose A of BIIB144 or a matching placebo via intravenous (IV) infusion on Day 1. |
|
| BIIB144 Cohort 2 | Experimental | Participants will receive Dose B of BIIB144 or a matching placebo via IV infusion on Day 1. |
|
| BIIB144 Cohort 3 | Experimental | Participants will receive Dose C of BIIB144 or a matching placebo via IV infusion on Day 1. |
|
| BIIB144 Cohort 4 | Experimental | Participants will receive Dose D of BIIB144 or a matching placebo via IV infusion on Day 1. |
|
| BIIB144 Cohort 5 | Experimental | Participants will receive Dose E of BIIB144 or a matching placebo via IV infusion on Day 1. |
|
| BIIB144 Cohort 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB144 | Drug | Administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to Day 280 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Serum Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUC0-last) of BIIB144 | Pre-dose and at multiple time points post-dose up to Day 280 | |
| Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of BIIB144 |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US Biogen Clinical Trial Center | Contact | 866-633-4636 | clinicaltrials@biogen.com | |
| Global Biogen Clinical Trial Center | Contact | clinicaltrials@biogen.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
Not provided
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Experimental |
Participants will receive Dose F of BIIB144 or a matching placebo via IV infusion on Day 1. |
|
| Placebo | Drug | Administered IV |
|
| Pre-dose and at multiple time points post-dose up to Day 280 |
| Maximum Observed Serum Concentration (Cmax) of BIIB144 | Pre-dose and at multiple time points post-dose up to Day 280 |
| Time to Maximum Observed Serum Concentration (Tmax) of BIIB144 | Pre-dose and at multiple time points post-dose up to Day 280 |
| Terminal Elimination Half-Life (t½) of BIIB144 | Pre-dose and at multiple time points post-dose up to Day 280 |
| Total Body Clearance (CL) of BIIB144 | Pre-dose and at multiple time points post-dose up to Day 280 |
| Volume of Distribution During the Terminal Elimination Phase (Vz) of BIIB144 | Pre-dose and at multiple time points post-dose up to Day 280 |