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

Phase 1

Not yet recruiting

• Conditions: Relative Bioequivalence
• Interventions: Drug: Sonelokimab

• Registration Number: NCT06994936
• Lead Sponsor: MoonLake Immunotherapeutics AG

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-20
• Study First Submitted QC: 2025-05-20
• Last Update Submitted: 2025-05-20
• Study Start: 2025-05-28
• Study First Posted: 2025-05-29
• Last Update Posted: 2025-05-29
• Primary Completion: 2025-10-16
• Study Completion: 2025-10-16

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sonelokimab via a PFS	Sonelokimab	-
Sonelokimab via an AI	Sonelokimab	-

Primary Outcome Measures

Name	Time	Method
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 area under the time concentration curve from time zero to timepoint with last measurable concentration (AUC0-t)

Secondary Outcome Measures

Name	Time	Method
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 upper arm
Immunogenicity of sonelokimab	64 days	Description of the prevalence of antidrug antibodies (ADAs)