BIIB145 for Healthy Subjects

Overseen By Global Biogen Clinical Trial Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Biogen

Disqualifiers: Blood disorders, Cardiac disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

104 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to ensure the safety of a new drug, BIIB145, and to understand its effects in the body before testing it on individuals with multiple sclerosis (MS). Participants will help researchers identify any health issues related to the drug and determine how food influences its processing. The trial includes several parts with different setups, such as taking the drug with or without food and comparing it to a placebo (a harmless pill with no active drug). Individuals in good health, without significant health issues, and weighing more than 50 kg (about 110 pounds) may be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Is there any evidence suggesting that BIIB145 is likely to be safe for humans?

Research into BIIB145 has just begun. This marks the first human testing, so researchers are still gathering information on its safety. The trial is in its early stages, focusing primarily on the safety of BIIB145 for people. Currently, specific information on side effects or how well people tolerate the drug is unavailable. However, testing on healthy volunteers indicates that researchers aim to ensure its safety before administering it to individuals with multiple sclerosis.

In early trials like this, researchers closely monitor how the body responds to the drug and any health issues that arise. This process helps identify potential risks. If BIIB145 is generally well-tolerated with few side effects, further testing can proceed in patients who might benefit from it. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for MS?

Researchers are excited about BIIB145 because it offers a potentially novel approach to treatment with its unique mechanism of action. Unlike standard treatments that often target symptoms, BIIB145 may work by affecting underlying pathways, offering a new angle on addressing the condition. Additionally, its oral administration in both single and multiple doses could provide more flexible and convenient dosing options for patients compared to current therapies, enhancing patient adherence and outcomes. This innovative approach has the potential to lead to more effective and efficient treatments, sparking interest in its development.

What evidence suggests that BIIB145 might be an effective treatment for multiple sclerosis?

Research shows that BIIB145 is a new treatment being tested in this trial for healthy subjects. Although direct evidence of its effectiveness for multiple sclerosis (MS) is not yet available, the drug targets specific parts of the disease. This trial focuses on assessing the drug's safety and how the body processes it, which are important first steps before testing its effectiveness for people with MS. This early research is essential to ensure the drug can be safely administered and reach the right areas in the body. The drug's mechanism suggests it could help MS patients in future studies. ^{1 2 3 6 7}

Who Is on the Research Team?

Medical Director

Principal Investigator

Biogen

Are You a Good Fit for This Trial?

This trial is for healthy adults with a BMI between 18 and 32 kg/m^2, weighing over 50 kg. Participants must be in good health as confirmed by medical history, physical exams, ECGs, and lab tests. They will help researchers learn about the safety of BIIB145 and how it's processed in the body.

Inclusion Criteria

Key

My BMI is between 18 and 32, and I weigh more than 50 kg.

I am in good health with no significant medical issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

1 visit (in-person)

Part 1: Single Ascending Dose (SAD)

Participants take a single dose of BIIB145 or placebo after fasting overnight. Participants stay at the research center for 4 days, with follow-up visits on Day 7 and Day 14.

Up to 6 weeks

3 visits (in-person)

Part 2: Food Effect Crossover

Participants take BIIB145 twice, once with food and once without, with a 7-day washout period between doses. Participants stay at the research center for 4 days per dosing period, with follow-up visits on Day 7 and Day 14.

Up to 8 weeks

5 visits (in-person)

Part 3: Multiple Ascending Dose (MAD)

Participants take a dose of BIIB145 or placebo once daily for 14 days after fasting overnight. Participants stay at the research center for 17 days, with follow-up visits on Day 21 and Day 28.

Up to 8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BIIB145

Trial Overview

The study investigates BIIB145's safety and how it's metabolized with or without food intake. It includes three parts: single-dose administration after fasting overnight; crossover design to test effects with/without food; multiple doses over two weeks after fasting.

How Is the Trial Designed?

Group I: Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 4C Experimental Treatment 2 Interventions

Participants will receive Dose F of BIIB145 or a matching placebo administered orally once daily for 14 days in a fasted state.

Group II: Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 3C Experimental Treatment 2 Interventions

Participants will receive Dose H of BIIB145 or a matching placebo administered orally once daily for 14 days in a fasted state.

Group III: Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 2C Experimental Treatment 2 Interventions

Participants will receive Dose C of BIIB145 or a matching placebo administered orally once daily for 14 days in a fasted state.

Group IV: Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 1C Experimental Treatment 2 Interventions

Participants will receive Dose B of BIIB145 or a matching placebo administered orally once daily for 14 days in a fasted state.

Group V: Part B [Food Effect]: BIIB145 Cohort 1B Experimental Treatment 1 Intervention

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.

Group VI: Part A [Single Ascending Dose (SAD)]: BIIB145 Cohort 1A Experimental Treatment 2 Interventions

Participants will receive Dose A of BIIB145 or a matching placebo on Day 1 in a fasted state.

Group VII: Part A (SAD): BIIB145 Cohort 7A Experimental Treatment 2 Interventions

Participants will receive Dose G of BIIB145 or a matching placebo on Day 1 in a fasted state.

Group VIII: Part A (SAD): BIIB145 Cohort 6A Experimental Treatment 2 Interventions

Participants will receive Dose F of BIIB145 or a matching placebo on Day 1 in a fasted state.

Group IX: Part A (SAD): BIIB145 Cohort 5A Experimental Treatment 2 Interventions

Participants will receive Dose E of BIIB145 or a matching placebo on Day 1 in a fasted state.

Group X: Part A (SAD): BIIB145 Cohort 4A Experimental Treatment 2 Interventions

Participants will receive Dose D of BIIB145 or a matching placebo on Day 1 in a fasted state.

Group XI: Part A (SAD): BIIB145 Cohort 3A Experimental Treatment 2 Interventions

Participants will receive Dose C of BIIB145 or a matching placebo on Day 1 in a fasted state.

Group XII: Part A (SAD): BIIB145 Cohort 2A Experimental Treatment 2 Interventions

Participants will receive Dose B of BIIB145 or a matching placebo on Day 1 in a fasted state.

Who Is Running the Clinical Trial?

Biogen

Lead Sponsor

Trials

655

Recruited

468,000+

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

Graduated from Queen's University, Kingston, Ontario, Canada

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07225517

A Study to Learn More About the Safety of BIIB145 and ...

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.

2.

investors.biogen.com

investors.biogen.com/news-releases/news-release-details/new-data-nusinersen-underscore-biogens-commitment-advancing

New Data for Nusinersen Underscore Biogen's ...

SPINRAZA has shown sustained efficacy across ages and SMA types with a well-established safety profile based on data in patients treated up to 10 years.

3.

investors.biogen.com

investors.biogen.com/news-releases/news-release-details/biogen-receives-european-commission-approval-high-dose-regimen

Biogen Receives European Commission Approval for High ...

The low dose regimen of SPINRAZA has shown efficacy across ages and SMA types with a well-established safety profile based on data in patients ...

4.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/BIIB/pressreleases/36649942/biogens-new-study-on-biib145-a-potential-game-changer-for-ms-treatment/

Biogen's New Study on BIIB145: A Potential Game- ...

The study tests BIIB145, an oral drug, against a placebo. It aims to assess safety and how the drug is processed with and without food.

5.

ir.ionis.com

ir.ionis.com/news-releases/news-release-details/new-england-journal-medicine-publishes-spinrazar-nusinersen

Release Details

When measuring changes from baseline, individuals who received SPINRAZA (n=84) achieved a 3.9 point mean improvement at Month 15, while ...

6.

gurufocus.com

gurufocus.com/news/4076703/biogen-biib-set-to-advance-new-drug-biib145-from-collaboration

Biogen (BIIB) Set to Advance New Drug BIIB145 from ...

Key Takeaways: Biogen's (BIIB) new drug, BIIB145, is a BTK degrader entering clinical trials, highlighting the company's innovative pipeline ...

7.

investors.biogen.com

investors.biogen.com/news-releases/news-release-details/new-higher-dose-nusinersen-efficacy-and-safety-data-presented

New Higher Dose Nusinersen Efficacy and Safety Data ...

SPINRAZA has shown sustained efficacy across ages and SMA types with a well-established safety profile based on data in patients treated up to ...