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NCT06741657 · ClinicalTrials.gov registry record · Phase 1
A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different Ways
A Phase 1 study of Healthy Volunteer, sponsored by Biogen.
- Active
- Registry status
- Phase 1
- Development phase
- 404
- Enrollment target
- 2
- Study locations
NCT06741657: Active Phase 1 study of Healthy Volunteer, sponsored by Biogen.
NCT06741657 is a Phase 1 study of Healthy Volunteer that is active but no longer recruiting, run by Biogen. The registered enrollment target is 404 participants, above the 198-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (104% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06741657, a Phase 1 study of Healthy Volunteer, is active but no longer recruiting, sponsored by Biogen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 404 participants
- Enrollment target
- 2
- Study locations
Study Summary
In this study, researchers will learn how the body processes litifilimab when it is given under the skin in 3 different ways. Currently, ongoing studies utilize pre-filled syringes (PFS) that can deliver litifilimab subcutaneously (SC), also known as under the skin. In this study, researchers want to learn more about new ways of delivering litifilimab SC using either an autoinjector (AI) or an on-body injector (OBI): Both devices are designed to deliver litifilimab in an automatic way, especially helping patients who may not be able to use their hands very well, or who may be afraid of needles. While the AI is handheld, the OBI device works by being placed on the skin and can help deliver the highest amount of litifilimab through a single injection. The main objective of this study is to learn how the body processes litifilimab after using the AI device or the OBI device, as compared to using the PFS method. The main questions researchers want to answer are: * What is the highest amount of litifilimab found in the blood after dosing? How much total litifilimab is found in the blood throughout the study? Researchers will also learn more about: Any medical problems the participants have during the study * Any injection site pain or reactions the participants may have. Any skin reactions to the OBI device * Any changes in the participants' overall health after receiving litifilimab. 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 4 weeks, after which selected participants will check into their study research center. * Participants will be randomly assigned to be in Part 1 or Part 2 of the study: * Part 1: Participants will receive SC injection(s) of litifilimab through either the AI device or through PFS. * Part 2: Participants will receive SC injection(s) of litifilimab through the OBI device or through PFS. * Participants will remain at their study research center for th
Conditions Studied
Interventions
- DEVICE AI
- DRUG Litifilimab
- DEVICE OBI
- DEVICE PFS
Study Locations (2)
Nevada
- Las Vegas Clinical Research Unit - Las Vegas
Texas
- Austin Clinical Research Unit - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 404 participants |
| Start Date | 2025-01-02 |
| Est. Completion | 2026-04-08 |
| Phase | Phase 1 |
What the registry record for NCT06741657 still lists
NCT06741657 is an interventional study that assigns participants to a tested intervention. The registered 404 participants enrollment target is mid-sized for trials with a published cap, above the 198-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (104% higher).
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 4 interventions - of which AI is the first listed.
NCT06741657 reports a single indexed study location in Nevada, Texas.
Frequently Asked Questions
What is clinical trial NCT06741657 about?
NCT06741657 is a clinical study titled "A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different Ways". In this study, researchers will learn how the body processes litifilimab when it is given under the skin in 3 different ways. Currently, ongoing studies utilize pre-filled syringes (PFS) that can deliver litifilimab subcutaneously (SC), also known as under the skin. In this study, researchers want ...
What is the current status of trial NCT06741657?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 404 participants. The study started on 2025-01-02. Estimated completion is 2026-04-08.
What conditions does trial NCT06741657 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT06741657?
The interventions under investigation include: AI (DEVICE), Litifilimab (DRUG), OBI (DEVICE), PFS (DEVICE).
Who is sponsoring clinical trial NCT06741657?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06741657 being conducted?
This trial has 2 study locations across Nevada, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06741657's enrollment target sits among peer trials
404 10th of 112 higher than 103 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer 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.
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