FKB327-005
Research type
Research Study
Full title
A Phase I, Randomised, Open-Label, Single-Dose Study to Assess the Relative Bioavailability of a Subcutaneous Dose of FKB327 when Administered Using Either a Pre-Filled Syringe, a Pre-Filled Auto Injector or a Vial with Disposable Syringe in Healthy Subjects
IRAS ID
184742
Contact name
Jim Bush
Contact email
Sponsor organisation
Fujifilm Kyowa Kirin Biologics Co., Ltd
Eudract number
2014-004469-26
Duration of Study in the UK
0 years, 6 months, 13 days
Research summary
FKB327 is a new investigational medication to treat Rheumatoid Arthritis (RA). RA is a long-term condition that causes pain, swelling and stiffness in the joints. FKB327 is similar to a product which is already approved called adalimumab (brand name - Humira).\nHumira is used in the treatment of rheumatoid arthritis, polyarticular juvenile\nidiopathic arthritis, enthesitis-related arthritis, ankylosing spondylitis,\naxial spondyloarthritis without radiographic evidence of ankylosing spondylitis,\npsoriatic arthritis, psoriasis, Crohn’s disease and ulcerative colitis\n\nThis will be a randomised [3 treatment arms of 65 subjects each will be randomly assigned to receive a single 40 mg of FKB327 administered via a vial/syringe, pre filled syringe (PFS) or auto injector (AI) in a 1:1:1 ratio], open label (volunteers and study staff will know the medication, dose and which drug delivery system being used for each volunteer), dose study conducted in healthy male and female volunteers.\n\nVolunteers will be screened within 28 days prior to dosing on Day1. Each volunteer will participate in 1 treatment period only, residing at the clinical research unit (CRU ) from Day –1 (the day before dosing) to Day 2 (24 hours post-dose).\n\nVolunteers will return to the CRU for outpatient visits on Days 3, 4, 5, 6, 7, 8, 9, 16, 23, 30, 37, 44, 51 and 65. \n\nFKB327 will be administered subcutaneously (SC) (under the skin) via either a vial/syringe, PFS or AI. All doses will be administered in accordance with a randomisation schedule in the fasted state in the morning of Day1. \n\nSubjects will be randomised to treatment according to weight in 2 strata: 50 to 75 kg and >75 to 100 kg. Randomisation will be such that within each weight stratum approximately equal numbers of subjects will be allocated to treatment with each of the 3 presentations of FKB327 and to each of 2 SC injection sites (abdomen and thighs)..
REC name
North East - York Research Ethics Committee
REC reference
15/NE/0218
Date of REC Opinion
6 Aug 2015
REC opinion
Further Information Favourable Opinion