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

NCT06994936 | Completed Phase 1

• 1 other identifier: M1095-HV-102
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Relative Bioequivalence

Outcome Measures

Primary Outcomes (3)

• Comparison of pharmacokinetics (PK) of an AI versus PFS administered single dose of sonelokimab

  To compare the PK of an AI versus PFS administered single-dose of sonelokimab in terms of maximum concentration (Cmax)

  64 days

• Comparison of pharmacokinetics (PK) of an AI versus PFS administered single dose of sonelokimab

  To compare the PK of an AI versus PFS administered single-dose of sonelokimab in terms of area under the time concentration curve to infinite time (AUC0-inf)

  64 days

• Comparison of pharmacokinetics (PK) of an AI versus PFS administered single dose of sonelokimab

  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)

  64 days

Secondary Outcomes (5)

• Assessment of safety and tolerability

  64 days

• Evaluation of the impact of injection site location on PK

  64 days

• Evaluation of the impact of injection site location on PK

  64 days

• Evaluation of the impact of injection site location on PK

  64 days

• Immunogenicity of sonelokimab

  64 days

Study Arms (2)

Sonelokimab via a PFS

EXPERIMENTAL

Drug: Sonelokimab

Sonelokimab via an AI

EXPERIMENTAL

Drug: Sonelokimab

Interventions

Sonelokimab DRUG

sonelokimab 120 mg administered subcutaneously via a PFS

Sonelokimab via a PFS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MoonLake Immunotherapeutics AG: lead

Study Sites (1)

Clinical Site

London, United Kingdom

Location

MeSH Terms

Interventions

sonelokimab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: June 5, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

GB (1)