An active controlled PK, PD study of RGB-14X compared with Xgeva in HV
Research type
Research Study
Full title
Randomised, Double-Blind, Single, 60 mg Fixed Dose, Parallel Comparative Pharmacokinetic and Pharmacodynamic (Phase 1) Study of RGB-14-X and Xgeva® in Healthy Adult Male Subjects
IRAS ID
289308
Contact name
Pablo ForteSoto
Contact email
Sponsor organisation
Gedeon Richter Plc.
Eudract number
2020-003953-32
Duration of Study in the UK
1 years, 6 months, 29 days
Research summary
This is a randomised, double-blind, parallel design study with single 60 mg doses of denosumab to compare pharmacokinetics (PK) and pharmacodynamics (PD) of RGB-14-X (test product) to Xgeva® (reference product). Pharmacokinetics refers to how the study treatments are absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body). Pharmacodynamics refers to the effects of the study treatments on the body. In addition, the study will assess how safe the study treatments are and how well these are tolerated after single doses of 60 mg denosumab were administered. Participants’ blood will also be tested for possible antibodies against denosumab that might have formed in the body after dosing (referred to as immunogenicity). No genetic testing will be performed in this study.\n\nThe study will be performed in a total of 172 healthy male participants at a single study centre, with 86 participants enrolled per treatment arm.\n\nThe study comprises a screening visit, an in-house treatment period, and a follow-up period of 250 days ending for each participant with an end-of-study visit. During the treatment period, each participant will receive a single dose of 60 mg denosumab, either as RGB-14-X or Xgeva®, by injection under the skin of his belly (subcutaneously).\n\nDenosumab is commercially available as Prolia® and Xgeva®. However, no clinical studies with RGB-14-X have been performed to date. The sponsor, Gedeon Richter Plc, is developing RGB-14-X as biosimilar to Xgeva®. Denosumab is a monoclonal antibody belonging to the class of drugs affecting bone structure and mineralisation. Denosumab is used for the treatment of adults with conditions involving bone, either as preventative treatment for skeletal related events in cancer cases or as alternative treatment to surgery for benign tumours.\n\nDenosumab is also used for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, for treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures and for Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.\n\nIn patients, the most commonly reported side effects of denosumab are hypocalcaemia, musculoskeletal pain, dyspnoea, and diarrhoea. For this study, the protocol has been designed to minimise the risk to the study participants.\n
REC name
London - Brent Research Ethics Committee
REC reference
20/LO/1101
Date of REC Opinion
2 Dec 2020
REC opinion
Further Information Favourable Opinion