Clinical trial NCT06994936: An Open-label Study in Healthy Adults to Evaluate the Relative Bioequivalence of a Single-dose Administration of Sonelokimab Either by a Prefilled Syringe or an Autoinjector
Official title: An Open-label, Randomized, Parallel-group, Single-dose Relative Bioequivalence Study of Sonelokimab Administered Subcutaneously Either by a Prefilled Syringe or an Autoinjector in Healthy Adults
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Relative Bioequivalence
Lead sponsor: MoonLake Immunotherapeutics AG
Sponsor class: INDUSTRY
First posted: 2025-05-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of pharmacokinetics (PK) of an AI versus PFS administered single dose of sonelokimab
timeFrame: 64 days
measure: Comparison of pharmacokinetics (PK) of an AI versus PFS administered single dose of sonelokimab
timeFrame: 64 days
measure: Comparison of pharmacokinetics (PK) of an AI versus PFS administered single dose of sonelokimab
timeFrame: 64 days
Secondary outcomes:
measure: Assessment of safety and tolerability
timeFrame: 64 days
measure: Evaluation of the impact of injection site location on PK
timeFrame: 64 days
measure: Evaluation of the impact of injection site location on PK
timeFrame: 64 days
measure: Evaluation of the impact of injection site location on PK
timeFrame: 64 days
measure: Immunogenicity of sonelokimab
timeFrame: 64 days
Other outcomes:
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Study officials:
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