Understanding how litifilimab is processed in the body with different injection methods
A Randomized, Open-Label, 2-Arm, 2-Part, Parallel Group Study to Assess the Pharmacokinetic Comparability of Subcutaneously Administered Litifilimab (BIIB059) Delivered by 3 Devices (Pre-Filled Syringe, Autoinjector, or On-Body Injector) in Healthy Participants
PHASE1 · Biogen · NCT06741657
This study is testing how well different injection methods for litifilimab work in healthy people to see which one is the easiest and safest to use.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 236 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Biogen (industry) |
| Drugs / interventions | litifilimab |
| Locations | 2 sites (Las Vegas, Nevada and 1 other locations) |
| Trial ID | NCT06741657 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate how the body processes litifilimab when administered subcutaneously using three different methods: an autoinjector, an on-body injector, and a pre-filled syringe. Researchers will assess the pharmacokinetics of litifilimab delivered via these devices in healthy participants. The study will also evaluate the safety and tolerability of each injection method. By comparing these delivery systems, the study seeks to identify the most effective way to administer litifilimab, particularly for individuals who may have difficulty with traditional injection methods.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 65 with a body mass index between 18.5 and 30 kg/m².
Not a fit: Patients with significant medical histories or conditions that could affect the study's outcomes may not benefit from participation.
Why it matters
Potential benefit: If successful, this study could lead to improved methods of administering litifilimab, making it easier and more accessible for patients.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving drug delivery methods, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria * Must have a body mass index between 18.5 and 30 kilograms per square meter (kg/m\^2), and a body weight ≥ 50 kg to ≤ 100 kg. * Must be in good health as determined by the investigator, based on medical history physical examination, electrocardiogram (ECG), and other screening evaluations. Key Exclusion Criteria * 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. * A positive diagnostic tuberculosis test result within 4 weeks prior to Enrollment (Day 1), defined as a positive QuantiFERON® test result or 2 successive indeterminate QuantiFERON test results. * History or positive test result for human immunodeficiency virus (HIV). * History of severe herpes infection such as herpetic encephalitis, ophthalmic herpes, or disseminated herpes. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Where this trial is running
Las Vegas, Nevada and 1 other locations
- Las Vegas Clinical Research Unit — Las Vegas, Nevada, United States (RECRUITING)
- Austin Clinical Research Unit — Austin, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: US Biogen Clinical Trial Center
- Email: clinicaltrials@biogen.com
- Phone: 866-633-4636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy Volunteer