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

MoonLake Immunotherapeutics

Status and phase

Completed

Phase 1

Conditions

Relative Bioequivalence

Treatments

Drug: Sonelokimab

Study type

Interventional

Funder types

Industry

Identifiers

NCT06994936

M1095-HV-102

Details and patient eligibility

About

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

Enrollment

120 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.