BA45871 - A study to evaluate the bioequivalence of subcutaneous sefaxersen via autoinjector or vial
Research type
Research Study
Full title
A Randomized, Open-label, Single-dose, Parallel-group Study to Investigate the Bioequivalence of Sefaxersen in Healthy Adult Participants following Subcutaneous Administration via an Autoinjector or Vial and Syringe.
IRAS ID
1011906
Contact name
Clinical Trial Accountable Regulatory Data and Content Chapter
Contact email
Sponsor organisation
F. Hoffmann-La Roche AG
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
Sefaxersen, the study drug, is currently being investigated in another ongoing clinical study as a possible new treatment for people with a kidney disease called primary immunoglobulin A nephropathy. Sefaxersen is designed to be specifically taken up into liver cells, limiting the drug from being taken into other tissues. Sefaxersen might reduce inflammatory damage to kidneys in patients with primary IgA nephropathy by lowering the activation of inflammatory components made in the liver. Currently, sefaxersen is being given to people as an injection under the skin (subcutaneously) using a vial and syringe. However, a new method called an autoinjector has been developed to inject the drug.
The purpose of this study is to see if the autoinjector can deliver the drug just as well as the vial and syringe, while making it easier to do so. More specifically, the study will evaluate how quickly and how much drug the autoinjector and the vial/syringe deliver into the bloodstream (called "bioequivalence"). It is hoped that the autoinjector will make it easier to give sefaxersen subcutaneously.
The study will also compare the safety of sefaxersen and how well it is tolerated using both delivery methods.
As sefaxersen is in the early stages of development, trialling it first in healthy volunteers allows researchers to make sure the drug is safe before testing it in vulnerable people and understand the effects of the drug/device/delivery method without the interference of existing health conditions. Participants will be selected by the Medicines Evaluation Unit (MEU) after being assessed and tested. The study duration is approximately 28 weeks, including a 5-day stay in the unit where they will be randomised and dosed, followed by 6 follow-up visits, of which 2 will be telephone visits. Some of the assessments and tests undergone by participants in the visits include physical examination, blood and urine samples.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
25/NW/0081
Date of REC Opinion
24 Jul 2025
REC opinion
Further Information Favourable Opinion