Healthy VolunteerPhase 1NCT07225517
A Study to Learn More About the Safety of BIIB145 and How it is Processed in the Body of Healthy Adult Participants
A Phase 1 study testing BIIB145 in people with Healthy Volunteer, run by Biogen at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- BIIB145
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2025to 2 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have a body mass index (BMI) between 18 and 32 kilograms per square metre (kg/m^2), inclusive, and a total body weight > 50 kilograms (kg) at Screening and Check-In.
- Must be in good health as determined by the Investigator, based on medical history and Screening evaluations. Good health is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
Who cannot join
- History of any clinically significant blood disorders or cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- History of, or ongoing, malignant disease, including solid tumours and hematologic malignancies (except for basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 1 year prior to Check-In).
- History of uncontrolled bleeding, or any risk of bleeding that, in the opinion of the Investigator, is clinically significant.
- History of torsades de pointes or additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, or family history of long QT syndrome), in the opinion of the Investigator.
- Any values of coagulation parameters including international normalized ratio, prothrombin time, and activated partial thromboplastin time above upper limit of normal at Screening or Check-In.
- Systolic blood pressure > 150 millimetres of mercury (mmHg) or < 90 mmHg after resting for 5 minutes in the supine position at Screening and prior to dosing. If out of range, testing may be repeated once at Screening and once prior to dosing.
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- Any live or attenuated immunization or vaccination given within 30 days prior to Check-In or planned to be given during the study period.
- Prior exposure to BIIB145 or any lymphocyte-depleting therapy or exposure to any lymphocyte-targeting therapy within 3 months prior to Check-In, or at least 5 half-lives or for the anticipated duration of the product's pharmacodynamics (PD) effects, whichever is longer.
- Known lumbar spine deformity, degenerative arthritis of the lumbar spine, history of lumbar spinal surgery, spinal infection, spinal mass or trauma, and/or known evidence on magnetic resonance imaging (MRI) contraindicating lumbar puncture (LP).
- NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Global Biogen Clinical Trial Center contact
United States1 site, 1 recruiting
- Recruiting
PPD Austin Clinic
Austin, Texas, 78744
512-747-1870
Jia Chang
About this study
Official title: A Phase 1, Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending-Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB145 in Healthy Adult Participants
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.
Read more
The main questions researchers want to answer are:
- How many participants have adverse events and serious adverse events during the study? An adverse event is a health problem that may or may not be caused by the study drug.
- How does BIIB145 affect the participants' overall health?
Researchers will also learn more about:
- How BIIB145 is processed by the body, with or without food.
This study will be done as follows:
- Participants will be screened to check if they can join the study. The screening period will be up to 28 days, after which participants will check into the study research center.
- There will be 3 parts to this study.
- Part 1: Participants will take a single dose of BIIB145 or a placebo after not eating overnight. 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. Participants in Part 1 will be in the study for up to 42 days.
- Part 2: This part of the study will have a "crossover" design. This means that all participants in Part 2 will all take BIIB145 twice, once with food and once without food. When taken with food, they will finish a meal about 30 minutes before their dose. Without food, they will not eat overnight before taking their dose. But, the order in which they take BIIB145 with or without food depends on the group to which they are randomly assigned. Participants in Part 2 will be in the study for up to 56 days.
- Part 3: Participants will take a dose of BIIB145 or the placebo once a day for 14 days. For each dose, participants will not eat overnight before taking it. Participants in Part 3 will be in the study for up to 56 days.
- For Part 1, participants will stay at the study research center for 4 days after screening. There will be 2 other visits to the center to check on participants' health on Day 7 and Day 14.
- For Part 2, at 2 different times, participants will stay at the center for a period of 4 days at a time, after screening. There will be a break of about 7 days between stays. There will be 3 other visits to the center to check on their health on Day 7 (of each period) and on Day 14.
- For Part 3, participants will stay at the center for 17 days after screening. There will be 2 other visits to the center to check on their health on Day 21 and Day 28.
Read the detailed description
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.
- Conditions
- Healthy Volunteer
- Being tested
- BIIB145, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB145Drug
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: BIIB145; Drug: Placebo |
| 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. Receives: Drug: BIIB145; Drug: Placebo |
| 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. Receives: Drug: BIIB145; Drug: Placebo |
| 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. Receives: Drug: BIIB145; Drug: Placebo |
| 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. Receives: Drug: BIIB145; Drug: Placebo |
| 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. Receives: Drug: BIIB145; Drug: Placebo |
| 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. Receives: Drug: BIIB145; Drug: Placebo |
| 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. Receives: Drug: BIIB145 |
| 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. Receives: Drug: BIIB145; Drug: Placebo |
| 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. Receives: Drug: BIIB145; Drug: Placebo |
| 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. Receives: Drug: BIIB145; Drug: Placebo |
| 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. Receives: Drug: BIIB145; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts A, B, and C: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Parts A and B: Up to Day 14; Part C: Up to Day 28
Secondary outcomes (6)
Parts A, B, and C: Area Under the Concentration-Time Curve (AUC) of BIIB145
Measured: 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
Measured: 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: Time to Maximum Observed Concentration (Tmax) of BIIB145
Measured: 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
Measured: 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
Measured: 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
Measured: Pre-dose and at multiple timepoints post-dose (Parts A and B: Up to Day 4; Part C: Up to Day 17)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2025
- Study start18 Dec 2025
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225517
- Sponsor's protocol ID
- 302HV101
- Status last verified
- Feb 2026
- First submitted
- 4 Nov 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending-Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB145 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07225517
- Acronym / sponsor ID
- 302HV101
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 6 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How many participants have adverse events and serious adverse events during the study? An adverse event is a health problem that may or may not be caused by the study drug.
- How does BIIB145 affect the participants' overall health?
Researchers will also learn more about:
- How BIIB145 is processed by the body, with or without food.
This study will be done as follows:
- Participants will be screened to check if they can join the study. The screening period will be up to 28 days, after which participants will check into the study research center.
- There will be 3 parts to this study.
- Part 1: Participants will take a single dose of BIIB145 or a placebo after not eating overnight. 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. Participants in Part 1 will be in the study for up to 42 days.
- Part 2: This part of the study will have a "crossover" design. This means that all participants in Part 2 will all take BIIB145 twice, once with food and once without food. When taken with food, they will finish a meal about 30 minutes before their dose. Without food, they will not eat overnight before taking their dose. But, the order in which they take BIIB145 with or without food depends on the group to which they are randomly assigned. Participants in Part 2 will be in the study for up to 56 days.
- Part 3: Participants will take a dose of BIIB145 or the placebo once a day for 14 days. For each dose, participants will not eat overnight before taking it. Participants in Part 3 will be in the study for up to 56 days.
- For Part 1, participants will stay at the study research center for 4 days after screening. There will be 2 other visits to the center to check on participants' health on Day 7 and Day 14.
- For Part 2, at 2 different times, participants will stay at the center for a period of 4 days at a time, after screening. There will be a break of about 7 days between stays. There will be 3 other visits to the center to check on their health on Day 7 (of each period) and on Day 14.
- For Part 3, participants will stay at the center for 17 days after screening. There will be 2 other visits to the center to check on their health on Day 21 and Day 28.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Part A [Single Ascending Dose (SAD)]: BIIB145 Cohort 1A | Experimental | Drug: BIIB145, Drug: PlaceboParticipants will receive Dose A of BIIB145 or a matching placebo on Day 1 in a fasted state. |
| Part A (SAD): BIIB145 Cohort 2A | Experimental | Drug: BIIB145, Drug: PlaceboParticipants will receive Dose B of BIIB145 or a matching placebo on Day 1 in a fasted state. |
| Part A (SAD): BIIB145 Cohort 3A | Experimental | Drug: BIIB145, Drug: PlaceboParticipants will receive Dose C of BIIB145 or a matching placebo on Day 1 in a fasted state. |
| Part A (SAD): BIIB145 Cohort 4A | Experimental | Drug: BIIB145, Drug: PlaceboParticipants will receive Dose D of BIIB145 or a matching placebo on Day 1 in a fasted state. |
| Part A (SAD): BIIB145 Cohort 5A | Experimental | Drug: BIIB145, Drug: PlaceboParticipants will receive Dose E of BIIB145 or a matching placebo on Day 1 in a fasted state. |
| Part A (SAD): BIIB145 Cohort 6A | Experimental | Drug: BIIB145, Drug: PlaceboParticipants will receive Dose F of BIIB145 or a matching placebo on Day 1 in a fasted state. |
| Part A (SAD): BIIB145 Cohort 7A | Experimental | Drug: BIIB145, Drug: PlaceboParticipants will receive Dose G of BIIB145 or a matching placebo on Day 1 in a fasted state. |
| Part B [Food Effect]: BIIB145 Cohort 1B | Experimental | Drug: BIIB145Participants 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. |
| Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 1C | Experimental | Drug: BIIB145, Drug: PlaceboParticipants will receive Dose B of BIIB145 or a matching placebo administered orally once daily for 14 days in a fasted state. |
| Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 2C | Experimental | Drug: BIIB145, Drug: PlaceboParticipants will receive Dose C of BIIB145 or a matching placebo administered orally once daily for 14 days in a fasted state. |
| Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 3C | Experimental | Drug: BIIB145, Drug: PlaceboParticipants will receive Dose H of BIIB145 or a matching placebo administered orally once daily for 14 days in a fasted state. |
| Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 4C | Experimental | Drug: BIIB145, Drug: PlaceboParticipants will receive Dose F of BIIB145 or a matching placebo administered orally once daily for 14 days in a fasted state. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Have a body mass index (BMI) between 18 and 32 kilograms per square metre (kg/m^2), inclusive, and a total body weight > 50 kilograms (kg) at Screening and Check-In.
- Must be in good health as determined by the Investigator, based on medical history and Screening evaluations. Good health is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
Key exclusion criteria (10 listed)
- History of any clinically significant blood disorders or cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- History of, or ongoing, malignant disease, including solid tumours and hematologic malignancies (except for basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 1 year prior to Check-In).
- History of uncontrolled bleeding, or any risk of bleeding that, in the opinion of the Investigator, is clinically significant.
- History of torsades de pointes or additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, or family history of long QT syndrome), in the opinion of the Investigator.
- Any values of coagulation parameters including international normalized ratio, prothrombin time, and activated partial thromboplastin time above upper limit of normal at Screening or Check-In.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIIB145Administered orally | Drug | Part A (SAD): BIIB145 Cohort 2A, Part A (SAD): BIIB145 Cohort 3A, Part A (SAD): BIIB145 Cohort 4A, Part A (SAD): BIIB145 Cohort 5A, Part A (SAD): BIIB145 Cohort 6A, Part A (SAD): BIIB145 Cohort 7A, Part A [Single Ascending Dose (SAD)]: BIIB145 Cohort 1A, Part B [Food Effect]: BIIB145 Cohort 1B, Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 1C, Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 2C, Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 3C, Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 4C |
| PlaceboAdministered orally | Drug | Part A (SAD): BIIB145 Cohort 2A, Part A (SAD): BIIB145 Cohort 3A, Part A (SAD): BIIB145 Cohort 4A, Part A (SAD): BIIB145 Cohort 5A, Part A (SAD): BIIB145 Cohort 6A, Part A (SAD): BIIB145 Cohort 7A, Part A [Single Ascending Dose (SAD)]: BIIB145 Cohort 1A, Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 1C, Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 2C, Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 3C, Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 4C |
Primary outcome
Parts A, B, and C: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Parts A and B: Up to Day 14; Part C: Up to Day 28
6 secondary outcomes
Parts A, B, and C: Area Under the Concentration-Time Curve (AUC) of BIIB145
Time frame: 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
Time frame: 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: Time to Maximum Observed Concentration (Tmax) of BIIB145
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre-dose and at multiple timepoints post-dose (Parts A and B: Up to Day 4; Part C: Up to Day 17)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Global Biogen Clinical Trial Center contact
Medical Director study director
Biogen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIIB145 in people with Healthy Volunteer, run by Biogen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US Biogen Clinical Trial Center (866-633-4636, clinicaltrials@biogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parts A, B, and C: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Parts A and Part B: Up to Day 14; Part C: Up to Day 28). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.