NCT06994936

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

An Open-label, Randomized, Parallel-group, Single-dose Relative Bioequivalence Study of Sonelokimab Administered Subcutaneously Either by a Prefilled Syringe or an Autoinjector in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: MoonLake Immunotherapeutics AG · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Sonelokimab	sonelokimab 120 mg administered subcutaneously via a PFS
DRUG	Sonelokimab	sonelokimab 120 mg administered subcutaneously via an AI

Timeline

• Start date: 2025-06-05
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2025-05-29
• Last updated: 2025-12-09

Locations

1 site across 1 country: United Kingdom