PK & safety study of SD GP2015 & Enbrel in healthy male volunteers
Research type
Research Study
Full title
A randomized, double blind, two-way cross-over study to determine the pharmacokinetics and safety of GP2015 and Enbrel® (EU-licensed) following a single dose of 50mg subcutaneous injection in healthy male subjects
IRAS ID
155075
Contact name
Annelize Koch
Contact email
Sponsor organisation
Hexal AG
Eudract number
2013-004902-25
ISRCTN Number
xx
Clinicaltrials.gov Identifier
xx
Research summary
This study will compare GP2015 to a product already on the market, namely Enbrel®. Both products contain etanercept as the active substance. GP2015 is being developed to be a similar biological medicinal product (also known as biosimilar) to the reference product Enbrel®, which is a drug already approved for the treatment of certain autoimmune diseases (diseases where the body's immune system attacks normal tissues, causing inflammation), such as Rheumatoid Arthritis (autoimmune inflammation of the joints) and Psoriasis (autoimmune inflammation of the skin), among others. GP2015 and Enbrel® inhibit inflammatory reactions by binding to certain proteins in the body, which decreases the immune response. It is expected that the treatment effect of GP2015 will be similar in comparison to Enbrel®. The main purpose of this study is to compare the study drug (GP2015) with the comparator drug (Enbrel®) to evaluate if they are bioequivalent, by investigating how the two drugs are taken up in the blood over time, in healthy subjects (this is called pharmacokinetic analysis). The study will also investigate how safe both drugs are, and how well they are tolerated after dosing (this is called safety and tolerability assessment). This study will recruit healthy, non smoking, males between the ages of 18 and 49 years (inclusive). Up to 54 research subjects will take part in the study. Blood samples for pharmacokinetic analysis will be collected. Vital signs, safety ECG measurements, safety laboratory assessments, adverse events and concomitant medications will be monitored throughout the entire investigational period.
REC name
London - Brent Research Ethics Committee
REC reference
14/LO/0696
Date of REC Opinion
7 May 2014
REC opinion
Favourable Opinion