PK Study of Gefurulimab SC Using Prefilled Syringe versus Autoinjector in Adult Healthy Participants
Research type
Research Study
Full title
A Phase 1, Open-label, Randomized, Parallel-group Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Immunogenicity, and Device Performance of ALXN1720 (Gefurulimab) Administered Subcutaneously Using Prefilled Syringe Versus Autoinjector in Adult Healthy Participants
IRAS ID
1008728
Contact name
Olivia Tong
Contact email
Sponsor organisation
Alexion Pharmaceuticals, Inc.
Research summary
This is a Phase 1, open-label, randomised, parallel-group study. The new medicine tested in this clinical trial is a compound called ALXN1720, developed by Alexion Pharmaceuticals, Inc., for treating diseases of the immune system.
The purpose of this study is to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, immunogenicity, and device performance of Gefurulimab in adult healthy volunteers following a single 600 mg Gefurulimab dose (consisting of 2 injections of 300 mg Gefurulimab each) administered subcutaneous (SC) by either prefilled syringe with needle safety device (PFS-SD) or AI. Data from this study will support the approvability of the Gefurulimab autoinjector (AI) drug-device combination product.
This clinical trial will recruit healthy males and females between the ages of 18 and 65 years. It is anticipated to enrol 50 participants out of the 174 mentioned in the protocol at Parexel EPCU London. Data from this study will support the approvability of the Gefurulimab AI drug-device combination product. The clinical trial will also investigate how safe and well tolerated the clinical trial medication is after dosing.
The study consists of 2 periods: a Screening Period (up to 70 days) and an Evaluation Period of 92 days. The total study duration is up to 162 days.REC name
London - Surrey Borders Research Ethics Committee
REC reference
23/LO/0837
Date of REC Opinion
20 Feb 2024
REC opinion
Further Information Unfavourable Opinion