Study to compare the PK/PD of 6 mg RGB-02 to 6 mg Neulasta (QCL117932)
Research type
Research Study
Full title
Randomised, Double-Blind, Single, 6 mg Fixed Dose, Two Treatment, Two-Period, Two-Sequence, Two-Way Crossover Comparative Pharmacokinetic and Pharmacodynamic (Phase I) Study of RGB-02 Compared to Neulasta® in Healthy Adult Subjects
IRAS ID
222499
Contact name
Norbert Jeszenői
Contact email
Sponsor organisation
Gedeon Richter Plc.
Eudract number
2016-005051-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 10 days
Research summary
The Sponsor is developing the study drug, RGB-02, for the potential treatment of neutropenia which can develop in cancer patients after they receive some types of chemotherapy. Patients with neutropenia have unusually low levels of neutrophils, a type of white blood cell. Neutrophils help the body fight infection so people with neutropenia are at a much higher risk of developing serious infection. The study drug is being developed with the aim to reduce the duration of neutropenia and also to reduce the incidence of serious fever in patients with neutropenia.
The purpose of the study is to demonstrate that RGB-02 and a product used to treat neutropenia, Neulasta®, are taken up by the body in a similar way and that they have similar effects on the body. The safety and tolerability of RGB-02 will also be assessed along with whether RGB-02 triggers the body to produce an immune response (immunogenicity).
The study will consist of 2 treatment periods involving up to 150 healthy male and female subjects. All participants will receive 6 mg of the study drug RGB-02 in one treatment period and 6 mg of the reference product Neulasta® in the other treatment period. Each product will be administered as an injection under the skin in the abdomen. The order in which participants will receive the two treatments will be randomised and the participants and people dosing will not know which treatment they are receiving (double-blinding). There will be a minimum of 46 days between the two treatment periods.
Subjects will remain in the clinical unit until the morning of Day 8 with return visits on Days 10, 14, 17 and 21. Safety assessments will be performed and blood samples will be taken at regular intervals. Subjects will return for a follow-up visit 46 days after their final dose.
REC name
HSC REC A
REC reference
17/NI/0040
Date of REC Opinion
15 Mar 2017
REC opinion
Further Information Favourable Opinion