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

Launched by MOONLAKE IMMUNOTHERAPEUTICS AG · May 20, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to study a medication called sonelokimab and to find out how well it works when given in two different ways: using a prefilled syringe or an autoinjector. Both methods involve injecting the medication just under the skin, and this study will help researchers determine if there are any differences in how the body absorbs the medication between the two methods. Healthy adults aged 18 to 55 who meet certain health criteria may be eligible to participate in this study.

To take part, volunteers must weigh more than 40 kg and have a body mass index (BMI) between 21 and 30. Participants will also need to be in good health, as determined by a medical evaluation. Women who are pregnant or breastfeeding cannot join, and men must agree to use protection if they are sexually active with a partner who could become pregnant. The trial is not yet recruiting participants, but if you’re interested, it's a good idea to talk to your doctor for more information about eligibility and what to expect during the study.

Gender

ALL

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.