Pharmacokinetics, Pharmocodynamics, Safety and Tolerability of Imlifidase on Healthy Japanese Men
Research type
Research Study
Full title
A PHASE 1 TRIAL EVALUATING THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY, AND TOLERABILITY OF IMLIFIDASE AFTER ADMINISTRATION OF A SINGLE INTRAVENOUS DOSE IN HEALTHY JAPANESE MEN
IRAS ID
1005630
Contact name
Charlotte Elfving
Contact email
Sponsor organisation
Hansa Biopharma AB
ISRCTN Number
ISRCTN45338135
Research summary
This clinical trial is a single centre, single dose, open label trial, recruiting healthy, non smoking, Japanese males aged between 20 years and 60 years. \n\nThe new medicine tested in this clinical trial is a compound called “imlifidase“. The Sponsor is developing imlifidase for treating various serious IgG mediated diseases. IgG is the most common type of antibody in your blood and other body fluids.\n\nThe main purpose of the clinical trial is to investigate how imlifidase is taken up, metabolised (chemically broken down), distributed through the body and excreted in Japanese people. The clinical trial will also try to see how safe imlifidase is and how well it is tolerated after dosing, including whether your body produce antibodies against imlifidase.\n\nThis clinical trial in Japanese people will help determine whether imlifidase can be given to Japanese patients in the future.\n8 healthy subjects aged 20 to 60 years will be administered imlifidase 0.25 mg/kg via infusion over a 15 minute period.\n\nThe trial comprises a screening visit between Day -42 and Day -7 , in-house stays of about 7 nights and 4 outpatient visits after the screening visit.
REC name
London - Brent Research Ethics Committee
REC reference
22/LO/0315
Date of REC Opinion
5 May 2022
REC opinion
Favourable Opinion