A PHASE 1, SAD, MAD, PK and PD STUDY OF ALXN1210 IN JAPANESE SUBJECTS
Research type
Research Study
Full title
A PHASE 1, OPEN-LABEL, SINGLE ASCENDING AND MULTIPLE SET DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ALXN1210 ADMINISTERED INTRAVENOUSLY TO HEALTHY JAPANESE SUBJECTS
IRAS ID
188441
Contact name
Jorg Taubel
Contact email
Sponsor organisation
Alexion Pharmaceuticals, Inc.
Eudract number
2015-005468-40
Duration of Study in the UK
0 years, 11 months, 10 days
Research summary
We are conducting a clinical study in healthy Japanese volunteers with an investigational drug known as ALXN1210 at Richmond Pharmacology Ltd clinical research unit. ALXN1210 is being developed by Alexion Pharmaceuticals, Inc. for the treatment of rare diseases related to the immune system such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). These diseases result in the breakdown of red blood cells and platelets (hemolysis) which can be life-threatening. Eculizumab is the only approved drug for treatment of PNH and aHUS and is also manufactured by Alexion. ALXN1210 works in the same way as eculizumab but may be given less frequently than eculizumab which may provide an alternative treatment for patients.\n\nALXN1210 has been given intravenously (iv) to healthy non-Japanese volunteers as single and multiple ascending (increasing) doses (i.e. SAD and MAD) studies; and showed a good safety profile but this is the first time ALXN1210 will be given to Japanese volunteers. The aim of this study is to compare the results (safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity) between Japanese and non-Japanese healthy volunteers from previous studies; in order to conduct further trials in Japanese subjects. It is anticipated that up to 22 healthy volunteers will participate in the study. There will be three dose groups in this study and volunteers will participate in the study for up to 27 weeks (dose groups 1 and 2) or 43 weeks (dose group 3), including a screening period of up to 70 days, a treatment period of 5 days (dose groups 1 and 2) or 112 days (dose group 3) and a 120-day observation period for safety and other assessments. \n\nWe will also assess safety parameters including physical examination, vital sign measurements, laboratory evaluations, electrocardiogram (ECG) and monitoring of adverse events (AEs). Volunteers will be vaccinated against meningitis and will be administered antibiotics as explained in section A6.2.\n
REC name
London - London Bridge Research Ethics Committee
REC reference
16/LO/0051
Date of REC Opinion
16 Feb 2016
REC opinion
Further Information Favourable Opinion