Comparative study for Orencia Biosimiliar (M834) in healthy subjects
Research type
Research Study
Full title
A Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, and Immunogenicity of M834 (Abatacept Biosimilar Candidate), US-Sourced Orencia®, and EU-Sourced Orencia® in Normal Healthy Volunteers
IRAS ID
205331
Contact name
Jim Bush
Contact email
Sponsor organisation
Momenta Pharmaceuticals
Eudract number
2016-000836-17
Duration of Study in the UK
0 years, 9 months, 5 days
Research summary
M834 is a new investigational medication considered a similar type medicinal product to ORENCIA®, which is a marketed product to treat conditions such as rheumatoid arthritis.
Following a screening period of up to 28 days, eligible subjects (healthy volunteers) will be admitted on Day -1 (day before dosing). Subjects will be randomized to one of 3 treatment arms in a 1:1:1 ratio: M834, US Orencia, or EU Orencia. Initially, a total of approximately 243 subjects are planned to be randomized (81 subjects to each type of medication). Randomization will by stratified by weight (≥50.0 to <75.0 kg, and ≥75.0 to 100.0 kg) and sex.
On Day 1, subjects will receive a single dose of 125 mg study drug, subcutaneously (under the skin) administered by an unblinded (staff members who only perform dosing will know the type of medication given to each subject but subjects will not know the type of medication they are receiving i.e blinded) delegated person(s).
All subjects will be followed for 85 days for assessments of pharmacokinetics (how much of the Study Drug gets into the blood stream and how long it takes absorb into the blood and to remove it) safety, tolerability and immunogenicity (ability of a particular substance, to provoke an immune response in the body of a human).
Subjects will remain in the clinical unit either 8 or 5 days as per protocol and will return for follow up visits on Days 11, 15, 22, 29, 36, 43, 57, 71, and 85.
During the study, there will be analysis of data to assess the required number of subjects. The sample size will not be reduced below the originally planned 243 randomized subjects, and the maximum sample size after any increase would be 366 randomized subjects.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/1179
Date of REC Opinion
20 Sep 2016
REC opinion
Further Information Favourable Opinion