PK and Safety of M923 via Auto Injector and Pre Filled Syringe
Research type
Research Study
Full title
A Randomized, Open-label, Two-arm, Parallel Group, Single Dose Study to Assess the Pharmacokinetics and Safety of M923 Administered via Auto injector or Prefilled Syringe, in Healthy Subjects.
IRAS ID
195102
Contact name
Tim Mant
Contact email
Sponsor organisation
Baxalta Innovations GmbH
Eudract number
2015-005200-29
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 30 days
Research summary
The purpose of this study is to compare the way the body handles the M923, (i.e. how much and how quickly M923 is absorbed into the blood stream following a single injection under the skin and how your immune system responds to the drug), also to compare tolerability and safety when administered using an auto-injector (a device designed to deliver a single dose of M923) or a prefilled syringe.\n\nAdalimumab is a monoclonal antibody which is used to treat chronic inflammatory diseases such as rheumatoid arthritis and psoriasis. Adalimumab is marketed for use in the USA (USHumira;Abbvie)and Europe (EUHumira;Abbvie). The Sponsor (Baxalta Innovations GmbH part of The Baxalta Healthcare Corporation) is developing a monoclonal antibody BAX 2923(M923)which is a similar biological medicinal product (biosimilar) to the marketed adalimumab preparations. \n\nThe pharmacokinetics, immunogenicity and safety of BAX 2923 were studied in the UK in healthy volunteers. The report for this study is expected by the end of 2015. If the effects of M923 and the blood levels are very similar to the marketed preparations of adalimumab it is hoped that M923 will be an effective alternative.\n\nThis study is being carried out on behalf of Sponsor by Quintiles Ltd. The study will be conducted at 2 locations Quintiles Ltd (London) and Quintiles Ltd (USA). The study will recruit 156 healthy male and female volunteers. After reviewing the inclusion/exclusion criteria to confirm their suitability, subjects will be randomly assigned to receive a single dose from either autoinjector or prefilled syringe. The study will take place over approximately 15 weeks and involves a screening period, residential period when volunteers will be admitted to the clinic for one in-patient stay (3days and 2 nights), followed by several outpatient visits and a final follow up visit (Day 71).\n\n
REC name
London - London Bridge Research Ethics Committee
REC reference
15/LO/2050
Date of REC Opinion
18 Jan 2016
REC opinion
Further Information Favourable Opinion