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In this study, researchers will learn for the first time about the safety of a study drug called BIIB145 and how the body responds to it. This is a "Phase 1" study. This kind of study is an early step in clinical research where the goal is to focus on the safety of the study drug. Another goal may be to learn how the study drug is processed by the body. BIIB145 was designed to help people with multiple sclerosis (MS). But, before it can be tested in people with MS, it must first be tested in healthy volunteers to learn about its safety and other effects.
The main goal of this study is to learn about the safety of BIIB145 and how it is processed by the body, with or without food.
The main questions researchers want to answer are:
Researchers will also learn more about:
This study will be done as follows:
The primary objective of the study is to evaluate the safety and tolerability of single and multiple ascending doses of BIIB145 in healthy adult participants.
The secondary objectives of the study are to evaluate the pharmacokinetics (PK) profile of single and multiple ascending doses of BIIB145 and its enantiomers in healthy adult participants; and the effect of food on the PK profile of BIIB145.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A [Single Ascending Dose (SAD)]: BIIB145 Cohort 1A | Experimental | Participants will receive Dose A of BIIB145 or a matching placebo on Day 1 in a fasted state. |
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| Part A (SAD): BIIB145 Cohort 2A | Experimental | Participants will receive Dose B of BIIB145 or a matching placebo on Day 1 in a fasted state. |
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| Part A (SAD): BIIB145 Cohort 3A | Experimental | Participants will receive Dose C of BIIB145 or a matching placebo on Day 1 in a fasted state. |
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| Part A (SAD): BIIB145 Cohort 4A | Experimental | Participants will receive Dose D of BIIB145 or a matching placebo on Day 1 in a fasted state. |
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| Part A (SAD): BIIB145 Cohort 5A | Experimental | Participants will receive Dose E of BIIB145 or a matching placebo on Day 1 in a fasted state. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB145 | Drug | Administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Parts A, B, and C: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Parts A and Part B: Up to Day 14; Part C: Up to Day 28 | |
| Parts A, B, and C: Number of Participants With Clinical Laboratory Abnormalities | Parts A and Part B: Up to Day 14; Part C: Up to Day 28 | |
| Parts A, B, and C: Number of Participants With Clinically Relevant Abnormalities in Vital Sign Parameters | Parts A and Part B: Up to Day 14; Part C: Up to Day 28 | |
| Part C: Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Events | Part C: Up to Day 28 | |
| Parts A, B, and C: Number of Participants With Potentially Clinically Relevant Abnormalities in 12-lead Electrocardiogram (ECG) Parameters | Parts A and B: Up to Day 14; Part C: Up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Parts A, B, and C: Area Under the Concentration-Time Curve (AUC) of BIIB145 | Pre-dose and at multiple timepoints post-dose (Parts A and B: Up to Day 4; Part C: Up to Day 17) | |
| Parts A, B, and C: Maximum Observed Concentration (Cmax) of BIIB145 | Pre-dose and at multiple timepoints post-dose (Parts A and B: Up to Day 4; Part C: Up to Day 17) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
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| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Austin Clinic | Recruiting | Austin | Texas | 78744 | United States |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| Part A (SAD): BIIB145 Cohort 6A | Experimental | Participants will receive Dose F of BIIB145 or a matching placebo on Day 1 in a fasted state. |
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| Part A (SAD): BIIB145 Cohort 7A | Experimental | Participants will receive Dose G of BIIB145 or a matching placebo on Day 1 in a fasted state. |
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| Part B [Food Effect]: BIIB145 Cohort 1B | Experimental | Participants will receive BIIB145 on Day 1 in the fasted state, followed by the fed state in the first sequence, and vice versa in the second sequence. A washout period of 7 days will be maintained between the two sequences. Dose will be determined based on safety and PK data of SAD Cohort 6A as well as safety, PK and pharmacodynamics (PD) data from previous cohorts. |
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| Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 1C | Experimental | Participants will receive Dose B of BIIB145 or a matching placebo administered orally once daily for 14 days in a fasted state. |
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| Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 2C | Experimental | Participants will receive Dose C of BIIB145 or a matching placebo administered orally once daily for 14 days in a fasted state. |
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| Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 3C | Experimental | Participants will receive Dose H of BIIB145 or a matching placebo administered orally once daily for 14 days in a fasted state. |
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| Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 4C | Experimental | Participants will receive Dose F of BIIB145 or a matching placebo administered orally once daily for 14 days in a fasted state. |
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| Placebo | Drug | Administered orally |
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| Parts A, B, and C: Time to Maximum Observed Concentration (Tmax) of BIIB145 | Pre-dose and at multiple timepoints post-dose (Parts A and B: Up to Day 4; Part C: Up to Day 17) |
| Parts A, B, and C: Elimination Half-Life (t1/2) of BIIB145 | Pre-dose and at multiple timepoints post-dose (Parts A and B: Up to Day 4; Part C: Up to Day 17) |
| Parts A, B, and C: Apparent Clearance (CL/F) of BIIB145 | Pre-dose and at multiple timepoints post-dose (Parts A and B: Up to Day 4; Part C: Up to Day 17) |
| Parts A, B, and C: Apparent Volume of Distribution (Vz/F) of BIIB145 | Pre-dose and at multiple timepoints post-dose (Parts A and B: Up to Day 4; Part C: Up to Day 17) |