Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06574828 · ClinicalTrials.gov registry record · Phase 1
A Study to Find Out How Multiple Doses of BIIB091 Affect the Electrical Activity of the Heart in Healthy Participants
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 69
- Enrollment target
NCT06574828: Completed Phase 1 study, sponsored by Biogen.
NCT06574828 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 69 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06574828, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 69 participants
- Enrollment target
Study Summary
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,
Interventions
- DRUG Moxifloxacin
- DRUG BIIB091
- DRUG BIIB091-matched Placebo
- DRUG Moxifloxacin-matched Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2024-08-29 |
| Est. Completion | 2025-03-22 |
| Phase | Phase 1 |
What the finished NCT06574828 record still lists
NCT06574828 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 4 interventions - of which Moxifloxacin is the first listed.
NCT06574828 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06574828 about?
NCT06574828 is a clinical study titled "A Study to Find Out How Multiple Doses of BIIB091 Affect the Electrical Activity of the Heart 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 ...
What is the current status of trial NCT06574828?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2024-08-29. Estimated completion is 2025-03-22.
What interventions are being tested in trial NCT06574828?
The interventions under investigation include: Moxifloxacin (DRUG), BIIB091 (DRUG), BIIB091-matched Placebo (DRUG), Moxifloxacin-matched Placebo (DRUG).
Who is sponsoring clinical trial NCT06574828?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06574828's enrollment target sits among peer trials
69 774th of 2000 higher than 1,225 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04020575 · 69 participants · Phase 1
Autologous huMNC2-CAR44 or huMNC2-CAR22 T Cells for Breast Cancer Targeting Cleaved Form of MUC1 (MUC1*)
- NCT04163614 · 69 participants · NA
Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients
- NCT04164641 · 69 participants · NA
Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic Gait Correction in Reducing Diabetic Foot Ulceration Or Subsequent Amputation in Patients With a History of a Diabetic Foot Ulceration
- NCT04493372 · 69 participants · NA
Deciphering Preserved Autonomic Function After Spinal Cord Injury
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI