Relative Bioequivalence
Conditions
Brief summary
This is a study to confirm the relative bioequivalence of sonelokimab administered subcutaneously via a prefilled syringe (PFS) or an autoinjector (AI) in healthy adult volunteers
Interventions
DRUGSonelokimab
sonelokimab 120 mg administered subcutaneously via a PFS
Sponsors
MoonLake Immunotherapeutics AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must be between 18 and 55 years of age with suitable veins for cannulation or repeated venipuncture . * Participants must have a body weight greater than 40 kg and body mass index (BMI) between 21 and 30 kg/m2, inclusive. * Participants who are overtly healthy as determined by medical evaluation including medical history, physician examination, laboratory tests, and cardiac monitoring. * Female participants are eligible to participate if they are not pregnant or breastfeeding * Male participants must be willing to use a condom when sexually active with a partner of childbearing potential during the study, unless surgically sterile.
Exclusion criteria
* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study. * History of clinically significant infections. * Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric. * History of hypersensitivity, intolerance, or severe adverse reaction to any drug compound, any history of anaphylaxis or angioedema, or any history of severe food allergy/intolerance requiring systemic treatment. * Participants with transaminase and liver function test results outside of the normal reference range, following a confirmatory test, if appropriate * Participants with other clinically significant laboratory test results that are likely to introduce additional risk factors or interfere with the study procedures or interpretation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of pharmacokinetics (PK) of an AI versus PFS administered single dose of sonelokimab | 64 days | To compare the PK of an AI versus PFS administered single-dose of sonelokimab in terms of maximum concentration (Cmax) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity of sonelokimab | 64 days | Description of the prevalence of antidrug antibodies (ADAs) |
| Assessment of safety and tolerability | 64 days | To assess the safety and tolerability of AI and PFS administered sonelokimab by treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs) |
| Evaluation of the impact of injection site location on PK | 64 days | Evaluation of the impact of injection site location on PK by capturing the relative bioavailability (F%) for thigh injection of sonelokimab compared to abdomen |
Countries
United Kingdom
Outcome results
None listed