Healthy Volunteer
Conditions
Brief 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 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.
Detailed description
The primary objective of this study is to assess the pharmacokinetic (PK) comparability of litifilimab administered via SC injection(s) of AI (Test Device 1) or SC injection(s) of OBI (Test Device 2), with SC injections of PFS (Reference) in healthy participants. The secondary objectives of this study are to evaluate the safety and tolerability following SC dose of litifilimab via AI, OBI, or PFS; to assess additional PK parameters following SC dose of litifilimab via AI, OBI, or PFS in healthy participants.
Interventions
DRUGLitifilimab
Administered as specified in the treatment arm.
DEVICEAI
Administered as specified in the treatment arm.
DEVICEOBI
Administered as specified in the treatment arm.
DEVICEPFS
Administered as specified in the treatment arm.
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 and 2: Maximum Observed Concentration (Cmax) of Litifilimab | Pre-dose and at multiple timepoints up to Week 22 |
| Part 1 and 2: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) | Pre-dose and at multiple timepoints up to Week 22 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 and 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From screening up to Week 22 | — |
| Part 1 and 2: Change From Baseline in the Injection Site Pain as Measured by Patient Reported Outcome (PRO) Using a Pain Intensity Numeric Rating Scale (PI-NRS) | Baseline, Day 1 | A PI-NRS scale will be used to assess overall injection site pain at different time points. The scale ranges from 0 to 10 where '0' indicates 'no pain' and '7-10' indicates 'severe pain'. |
| Part 1 and 2: Percentage of Participants With Mild, Moderate, Severe, or no Injection Site Reactions | Up to Week 1 | — |
| Part 2: Percentage of Participants With Adhesive Contact Skin Reactions as Measured by Dermal Response and Other Effects Scales | Up to Week 1 | A dermal response scale will be used to assess the adhesive contact skin reactions. The scale ranges from 0 to 7, where '0' indicates 'no evidence of irritation' and '7' indicates 'strong reaction spreading beyond the application site'. The other effects scale ranges from 'A(0)' to 'H(3)', where a 'A(0)' indicates a slightly glazed appearance and 'H(3)' indicates small petechial erosions and/or scabs. |
| Part 1 and 2: Number of Participants With Change From Baseline in Clinically Significant Vital Signs Abnormalities | Baseline, up to Week 22 | — |
| Part 1 and 2: Number of Participants With Change From Baseline in Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities | Baseline, up to Week 4 | — |
| Part 1 and 2: Number of Participants With Change From Baseline in Clinically Significant Laboratory Evaluation Abnormalities | Baseline, up to Week 22 | — |
| Part 1 and 2: Number of Participants With Change From Baseline in Clinically Significant Physical Examination Abnormalities | Baseline, up to Week 22 | — |
| Part 1 and 2: Time to Reach Cmax (Tmax) of Litifilimab | Pre-dose and at multiple timepoints up to Week 22 | — |
| Part 1 and 2: Terminal Elimination Half-life (t1/2) of Litifilimab | Pre-dose and at multiple timepoints up to Week 22 | — |
| Part 1 and 2: Apparent Total Clearance (CL/F) of Litifilimab | Pre-dose and at multiple timepoints up to Week 22 | — |
| Part 1 and 2: Volume of Distribution (Vd/F) of Litifilimab | Pre-dose and at multiple timepoints up to Week 22 | — |
| Part 1 and 2: Area Under the Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUC0-last) of Litifilimab | Pre-dose and at multiple timepoints up to Week 22 | — |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Biogen
Outcome results
None listed