A Study to Evaluate Zilucoplan Injected Subcutaneously Either by a Prefilled Syringe or an Auto-injector in Healthy Adult Participants

Summary

The purpose of this study is to assess the bioequivalence pharmacokinetics, safety, tolerability and device deficiencies of zilucoplan (ZLP) in healthy adult participants

Timeline

Start

2024-08-05

Primary completion

2024-11-26

Completion

2024-11-26

Outcome

Met primary endpoint

registry analysis (equivalence test); ZLP-PFS vs ZLP-AI; GLSM ratio 0.9809 (90% CI 0.9529 to 1.0097); Mixed Effects model NCT06511076 ↗

registry analysis (equivalence test); ZLP-PFS vs ZLP-AI; GLSM Ratio 0.9819 (90% CI 0.9543 to 1.0102); Mixed Effects model NCT06511076 ↗

registry analysis (equivalence test); ZLP-PFS vs ZLP-AI; GLSM ratio 0.9996 (90% CI 0.9594 to 1.0416); Mixed Effects model NCT06511076 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zilucoplan	Peptide	—	Subcutaneous

Indications

No indication recorded.