Phase 1 study comparing proposed biosimilar denosumab GP2411 & Xgeva
Research type
Research Study
Full title
A double-blind, randomized, three-arm parallel group phase 1 study to compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of GP2411 (proposed biosimilar denosumab), EU-authorized Xgeva® and US-licensed Xgeva® after a single subcutaneous injection of 35 mg in healthy male subjects
IRAS ID
1003849
Contact name
Anna Riml
Contact email
Sponsor organisation
Hexal AG
Eudract number
2019-001651-39
Research summary
This study is being conducted to find out if the drug GP2411 is safe and can be used in the same way as the drug Xgeva®. Both, GP2411 and Xgeva® have the same ingredient called denosumab. Denosumab is an approved drug that is available in pharmacies under the trade names Prolia® and Xgeva®. Prolia® is used for the treatment of osteoporosis (bone loss) in both, postmenopausal women (i.e. after the last menstrual period) and men, with an increased risk of fractures. Xgeva® is used in either the prevention or the treatment of certain bone related complications in patients suffering from different forms of cancers.
This study is a part of a process aimed at making a new drug product, GP2411 available for the treatment of the disease conditions mentioned above, which the drug product Xgeva® is already approved for. The process involves the conduct of a comparative study between the two, referred to as a biosimilar study, which means that the two treatments compared have the same ingredient (medication molecule) and the study tries to demonstrate that the two products have similar properties.
The study will compare GP2411 and Xgeva® in terms of how quickly and to what extent they are absorbed and eliminated from the body pharmacokinetics), and what the effect of the study treatment is on the body (pharmacodynamics). It will also investigate if in comparison to Xgeva®, GP2411 is as safe and has similar side effects. In addition, the comparison will analyse whether (and if so to what degree) the study treatment provokes an immune response (this is called immunogenicity), which is determined by looking for the development of antibodies against GP2411 or Xgeva® in your blood.
This study will enrol 501 healthy male participants who will receive one single subcutaneous injection of either GP2411 or Xgeva. The study is planned for a duration of up to 44 weeks (9 months) at 3 sites in Germany and UK.
This study is sponsored (funded) by Hexal AG, a Sandoz company.
REC name
North East - York Research Ethics Committee
REC reference
21/NE/0118
Date of REC Opinion
13 Aug 2021
REC opinion
Favourable Opinion