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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2025-12-09
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
- DRUG
-
Sonelokimab
sonelokimab 120 mg administered subcutaneously via an AI
- DRUG
-
Sonelokimab
sonelokimab 120 mg administered subcutaneously via a PFS
Sponsors & Collaborators
-
MoonLake Immunotherapeutics AG
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-06-05
- Primary Completion
- 2025-11-01
- Completion
- 2025-11-01
Countries
- United Kingdom
Study Locations
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