Healthy VolunteerPhase 1NCT06574828

A Study to Find Out How Multiple Doses of BIIB091 Affect the Electrical Activity of the Heart in Healthy Participants

A Phase 1 study testing BIIB091 and Moxifloxacin in people with Healthy Volunteer, run by Biogen at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer
What is being tested?: BIIB091 and Moxifloxacin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 69 participants
Where: 1 siteUnited States
Study dates: 29 Aug 2024to 22 Mar 2025
Phase: Phase 1
Are there results?: None posted in the registry

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 between 18 and 32 kilograms per meter square (kg/m^2), inclusive, and a total body weight > 50 kg, at screening and Day -2.
Must be in good health as determined by the Investigator, based on medical history and Screening evaluations.
Negative polymerase chain reaction (PCR) test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at check-in (Day -2).

Who cannot join

History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
Clinically significant 12-lead ECG findings at screening and prior to first dose, including confirmed demonstration of QTcF > 430 milliseconds (ms), QRS > 120 ms, PR > 220 ms, or heart rate < 45 beats per minutes (bpm) based on the average of triplicate measurements, early repolarization, or any other clinically significant 12-lead ECG abnormalities as determined by the Investigator.
History of torsades de pointes or additional risk factors for torsades de pointes.
History of, or positive test result at Screening for, human immunodeficiency virus, hepatitis B virus, or hepatitis C virus infection.
Use of any prescription or over-the-counter medication (including herbal supplements) that are known to prolong QT/QTc interval or induce torsades de pointes.
Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia), as determined by the Investigator, within 90 days prior to Screening or between Screening and Check-in.
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

Austin Clinic PPD
Austin, Texas, 78744

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo- and Positive-Controlled (Moxifloxacin), Parallel Study With a Nested Crossover to Assess the Effect of Multiple Oral Therapeutic and Supratherapeutic Doses of BIIB091 on Cardiac Repolarization in Healthy Participants

In this study, researchers will learn how the heart reacts to multiple doses of BIIB091 in healthy participants. In previous studies looking at BIIB091, researchers have found that a certain range of doses can cause changes in the electrical activity of the heart. In this study, researchers want to learn more about that activity after participants take BIIB091 at lower and higher doses for 5 days. The main objective of this study is to learn how the heart's electrical activity changes after taking BIIB091. To measure this, researchers will look at something called the QT interval corrected for heartbeat, also known as "QTc". This represents the time it takes for the heart to contract and relax. A QT interval that is too long means that the heart's electrical system is taking longer than normal to recharge between heartbeats. This could increase the risk of abnormal heartbeats that may lead to sudden death.

The main questions researchers want to answer are:

What is the change in the participants' QTc after taking BIIB091?

Researchers will also learn more about:

Any changes in other measures of the heart's electrical activity
How the body processes BIIB091, as well as something called "M23", which is made in the body when BIIB091 is broken down
Any medical problems the participants have during the study
Any changes in the participants' overall health during the study

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 29 days, after which participants will check into their study research center.
Participants will be randomly assigned to be in 1 of 2 groups:
Group 1: Participants will take a low dose of BIIB091 for 5 days followed by a high dose of BIIB091 for 5 days.
Group 2: Participants will take a single dose of moxifloxacin. Moxifloxacin is an antibiotic used to treat bacterial infections. Researchers are using it in this study to compare to BIIB091, because it is known to cause abnormal changes to the heart's electrical activity.
Participants in both Group 1 and Group 2 will also take a placebo while at the study research center. A placebo looks like the study drug or moxifloxacin, but does not have any real medicine in it.
Participants will remain at their study research center for 15 days. Afterwards, there will be a follow-up visit 11 to 14 days after each participant's last dose. Each participant will be in the study for up to 57 days.

Read the detailed description

The primary objective of this study is to evaluate the effect of BIIB091 and its metabolite M23 following multiple therapeutic and supratherapeutic doses of BIIB091 on QTc intervals in healthy participants. The secondary objectives of this study are: to evaluate the effect of BIIB091 and its metabolite M23 following multiple therapeutic and supratherapeutic doses of BIIB091 on other electrocardiogram (ECG) parameters (heart rate [HR], pulse rate [PR] and QRS intervals, and ECG morphology); to demonstrate assay sensitivity of the study to detect a QTc effect using moxifloxacin as a positive control; to assess the pharmacokinetics (PK) of BIIB091 and its metabolite M23, following multiple oral dose administrations in healthy participants; to evaluate the safety and tolerability of BIIB091 in healthy participants.

Conditions: Healthy Volunteer
Being tested: BIIB091, Moxifloxacin, BIIB091-matched Placebo, Moxifloxacin-matched Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BIIB091Drug
Administered as specified in the treatment arm.
MoxifloxacinDrug
Administered as specified in the treatment arm.
BIIB091-matched PlaceboDrug
Administered as specified in the treatment arm.
Moxifloxacin-matched PlaceboDrug
Administered as specified in the treatment arm.

Study groups in NCT06574828
Study group	Role	What they receive
BIIB091, BIIB091-matched placebo, Moxifloxacin-matched placebo	Experimental	Participants will receive BIIB091, BIIB091-matched placebo, and moxifloxacin-matched placebo orally during the inpatient period (Days -1 to 13). Receives: Drug: BIIB091; Drug: BIIB091-matched Placebo; Drug: Moxifloxacin-matched Placebo
Moxifloxacin, Moxifloxacin-matched placebo, BIIB091-matched placebo	Active comparator	Participants will receive moxifloxacin, moxifloxacin-matched placebo, and BIIB091-matched placebo orally during the inpatient period (Days -1 to 13). Receives: Drug: Moxifloxacin; Drug: BIIB091-matched Placebo; Drug: Moxifloxacin-matched Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in QT Interval Corrected for Heart Rate (QTc) for BIIB091
Measured: Baseline (Day -1) up to Day 14
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) for Metabolite 23 (M23)
Measured: Baseline (Day -1) up to Day 14

Secondary outcomes (13)

Change From Baseline in Heart Rate (ΔHR) for BIIB091 and M23
Measured: Baseline (Day -1) up to Day 14
Change From Baseline in Pulse Rate Interval (ΔPR) for BIIB091 and M23
Measured: Baseline (Day -1) up to Day 14
Change From Baseline in QRS Interval (ΔQRS) for BIIB091 and M23
Measured: Baseline (Day -1) up to Day 14
Number of Participants With Categorical Outliers for QT Interval Corrected Formula for Heart Rate (QTcF), HR, PR, and QRS for BIIB091 and M23
Measured: From Day -1 up to Day 14
Number of Participants With Treatment-Emergent Changes in ECG Morphology for BIIB091 and M23
Measured: From Day -1 up to Day 14
Time to Maximum Measured Plasma Concentration (Tmax) of BIIB091 and M23
Measured: Pre-dose and at multiple timepoints up to Day 14
Maximum Measured Plasma Concentration (Cmax) of BIIB091 and M23
Measured: Pre-dose and at multiple timepoints up to Day 14
Area Under the Plasma Concentration Versus Time Curve to 24 Hours (AUC0-24) of BIIB091 and M23
Measured: Pre-dose and at multiple timepoints up to Day 14
Area Under the Plasma Concentration Versus Time Curve to the Last Measurable Concentration (AUC0-t) of BIIB091 and M23
Measured: Pre-dose and at multiple timepoints up to Day 14
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From Day -1 up to end of study follow-up (up to 28 days)
Number of Participants With Clinically Significant Vital Signs Abnormalities
Measured: From Day -1 up to end of study follow-up (up to 28 days)
Number of Participants With ECG Abnormalities
Measured: From Day 1 up to Day 14
Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Measured: At Days 4, 14 and follow-up (up to 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Aug 202422 Mar 2025

First posted28 Aug 2024
Study start29 Aug 2024
Primary completion22 Mar 2025
Study completion22 Mar 2025

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: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06574828
Sponsor's protocol ID: 257HV109
Status last verified: Mar 2025
First submitted: 26 Aug 2024
Last updated: 28 Mar 2025
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/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo- and Positive-Controlled (Moxifloxacin), Parallel Study With a Nested Crossover to Assess the Effect of Multiple Oral Therapeutic and Supratherapeutic Doses of BIIB091 on Cardiac Repolarization in Healthy Participants
ClinicalTrials.gov ID: NCT06574828
Acronym / sponsor ID: 257HV109
Conditions: Healthy Volunteer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: BiogenIndustry (pharma, biotech, devices)
Study start: 29 Aug 2024 (actual)
Primary completion: 22 Mar 2025 (actual)
Study completion: 22 Mar 2025 (actual)
First posted: 28 Aug 2024 (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.

The main questions researchers want to answer are:

What is the change in the participants' QTc after taking BIIB091?

Researchers will also learn more about:

Any changes in other measures of the heart's electrical activity
How the body processes BIIB091, as well as something called "M23", which is made in the body when BIIB091 is broken down
Any medical problems the participants have during the study
Any changes in the participants' overall health during the study

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 29 days, after which participants will check into their study research center.
Participants will be randomly assigned to be in 1 of 2 groups:
Group 1: Participants will take a low dose of BIIB091 for 5 days followed by a high dose of BIIB091 for 5 days.
Group 2: Participants will take a single dose of moxifloxacin. Moxifloxacin is an antibiotic used to treat bacterial infections. Researchers are using it in this study to compare to BIIB091, because it is known to cause abnormal changes to the heart's electrical activity.
Participants in both Group 1 and Group 2 will also take a placebo while at the study research center. A placebo looks like the study drug or moxifloxacin, but does not have any real medicine in it.
Participants will remain at their study research center for 15 days. Afterwards, there will be a follow-up visit 11 to 14 days after each participant's last dose. Each participant will be in the study for up to 57 days.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
BIIB091, BIIB091-matched placebo, Moxifloxacin-matched placebo	Experimental	Drug: BIIB091, Drug: BIIB091-matched Placebo, Drug: Moxifloxacin-matched PlaceboParticipants will receive BIIB091, BIIB091-matched placebo, and moxifloxacin-matched placebo orally during the inpatient period (Days -1 to 13).
Moxifloxacin, Moxifloxacin-matched placebo, BIIB091-matched placebo	Active comparator	Drug: Moxifloxacin, Drug: BIIB091-matched Placebo, Drug: Moxifloxacin-matched PlaceboParticipants will receive moxifloxacin, moxifloxacin-matched placebo, and BIIB091-matched placebo orally during the inpatient period (Days -1 to 13).

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Have a body mass index between 18 and 32 kilograms per meter square (kg/m^2), inclusive, and a total body weight > 50 kg, at screening and Day -2.
Must be in good health as determined by the Investigator, based on medical history and Screening evaluations.
Negative polymerase chain reaction (PCR) test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at check-in (Day -2).

Key exclusion criteria (7 listed)

History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
Clinically significant 12-lead ECG findings at screening and prior to first dose, including confirmed demonstration of QTcF > 430 milliseconds (ms), QRS > 120 ms, PR > 220 ms, or heart rate < 45 beats per minutes (bpm) based on the average of triplicate measurements, early repolarization, or any other clinically significant 12-lead ECG abnormalities as determined by the Investigator.
History of torsades de pointes or additional risk factors for torsades de pointes.
History of, or positive test result at Screening for, human immunodeficiency virus, hepatitis B virus, or hepatitis C virus infection.
Use of any prescription or over-the-counter medication (including herbal supplements) that are known to prolong QT/QTc interval or induce torsades de pointes.

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
BIIB091Administered as specified in the treatment arm.	Drug	BIIB091, BIIB091-matched placebo, Moxifloxacin-matched placebo
MoxifloxacinAdministered as specified in the treatment arm.	Drug	Moxifloxacin, Moxifloxacin-matched placebo, BIIB091-matched placebo
BIIB091-matched PlaceboAdministered as specified in the treatment arm.	Drug	BIIB091, BIIB091-matched placebo, Moxifloxacin-matched placebo, Moxifloxacin, Moxifloxacin-matched placebo, BIIB091-matched placebo
Moxifloxacin-matched PlaceboAdministered as specified in the treatment arm.	Drug	BIIB091, BIIB091-matched placebo, Moxifloxacin-matched placebo, Moxifloxacin, Moxifloxacin-matched placebo, BIIB091-matched placebo

Primary outcome

Change From Baseline in QT Interval Corrected for Heart Rate (QTc) for BIIB091
Time frame: Baseline (Day -1) up to Day 14
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) for Metabolite 23 (M23)
Time frame: Baseline (Day -1) up to Day 14

13 secondary outcomes

Change From Baseline in Heart Rate (ΔHR) for BIIB091 and M23
Time frame: Baseline (Day -1) up to Day 14
Change From Baseline in Pulse Rate Interval (ΔPR) for BIIB091 and M23
Time frame: Baseline (Day -1) up to Day 14
Change From Baseline in QRS Interval (ΔQRS) for BIIB091 and M23
Time frame: Baseline (Day -1) up to Day 14
Number of Participants With Categorical Outliers for QT Interval Corrected Formula for Heart Rate (QTcF), HR, PR, and QRS for BIIB091 and M23
Time frame: From Day -1 up to Day 14
Number of Participants With Treatment-Emergent Changes in ECG Morphology for BIIB091 and M23
Time frame: From Day -1 up to Day 14
Time to Maximum Measured Plasma Concentration (Tmax) of BIIB091 and M23
Time frame: Pre-dose and at multiple timepoints up to Day 14
Maximum Measured Plasma Concentration (Cmax) of BIIB091 and M23
Time frame: Pre-dose and at multiple timepoints up to Day 14
Area Under the Plasma Concentration Versus Time Curve to 24 Hours (AUC0-24) of BIIB091 and M23
Time frame: Pre-dose and at multiple timepoints up to Day 14
Area Under the Plasma Concentration Versus Time Curve to the Last Measurable Concentration (AUC0-t) of BIIB091 and M23
Time frame: Pre-dose and at multiple timepoints up to Day 14
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day -1 up to end of study follow-up (up to 28 days)
Number of Participants With Clinically Significant Vital Signs Abnormalities
Time frame: From Day -1 up to end of study follow-up (up to 28 days)
Number of Participants With ECG Abnormalities
Time frame: From Day 1 up to Day 14
Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Time frame: At Days 4, 14 and follow-up (up to 28 days)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
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. This study is not recruiting at the moment.

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 BIIB091 and Moxifloxacin 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 28 Mar 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in QT Interval Corrected for Heart Rate (QTc) for BIIB091 (time frame: Baseline (Day -1) up to Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06574828.

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 28 Mar 2025.