Litifilimab for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
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 the first 8 days. After that, there will be a follow-up period for 17 weeks during which participants return to the center a total of 6 times.Each participant will be in the study for about 22 weeks.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Who Is on the Research Team?
Medical Director
Principal Investigator
Biogen
Are You a Good Fit for This Trial?
This trial is for healthy individuals with a body mass index (BMI) between 18.5 and 30 kg/m^2, weighing at least 50 kg but not over 100 kg. They must be in good health as determined by medical history, physical exams, ECGs, and other evaluations.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive SC injection(s) of litifilimab through AI, OBI, or PFS and remain at the research center for 8 days
Follow-up
Participants are monitored for safety, tolerability, and pharmacokinetic parameters after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Litifilimab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Biogen
Lead Sponsor
Daniel Quirk
Biogen
Chief Medical Officer
MD
Christopher A. Viehbacher
Biogen
Chief Executive Officer since 2022
Graduated from Queen's University, Kingston, Ontario, Canada