236 Participants Needed

Litifilimab for Healthy Subjects

Recruiting at 1 trial location
GB
UB
Overseen ByUS Biogen Clinical Trial Center
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Biogen
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

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.

Research Team

MD

Medical Director

Principal Investigator

Biogen

Eligibility Criteria

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

I am in good health according to my doctor's evaluation.
My BMI is between 18.5 and 30, and my weight is between 50kg and 100kg.
I meet the main requirements to join the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks
1 visit (in-person)

Treatment

Participants receive SC injection(s) of litifilimab through AI, OBI, or PFS and remain at the research center for 8 days

8 days
Continuous stay at the research center

Follow-up

Participants are monitored for safety, tolerability, and pharmacokinetic parameters after treatment

17 weeks
6 visits (in-person)

Treatment Details

Interventions

  • Litifilimab
Trial Overview Researchers are testing how litifilimab is processed when given under the skin using three methods: an autoinjector (AI), an on-body injector (OBI), or pre-filled syringes (PFS). The study compares the maximum blood levels of litifilimab and total exposure after dosing with each method.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Part 2: OBI versus PFSExperimental Treatment3 Interventions
Participants will receive SC dose of litifilimab injection via OBI or PFS on Day 1 of the study.
Group II: Part 1: AI versus PFSExperimental Treatment3 Interventions
Participants will receive SC dose of litifilimab injection via AI or PFS on Day 1 of the study.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Biogen

Lead Sponsor

Trials
655
Recruited
468,000+
Daniel Quirk profile image

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher profile image

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

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

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