Status:
COMPLETED
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
Lead Sponsor:
MoonLake Immunotherapeutics AG
Conditions:
Relative Bioequivalence
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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
- 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
- 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.
Key Trial Info
Start Date :
June 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06994936
Start Date
June 5 2025
End Date
November 1 2025
Last Update
December 9 2025
Active Locations (1)
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1
Clinical Site
London, United Kingdom