Safety Tolerability and PK study of GBR900 in Osteoarthritis Patients

• Research type

  Research Study

• Full title

  A Phase 1, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GBR 900 in Osteoarthritis Patients

• IRAS ID

  204499

• Contact name

  Lalit Lakhwani

• Contact email

  Lalit.lakhwani@glenmarkpharma.com

• Sponsor organisation

  Glenmark Pharmaceuticals SA

• Eudract number

  2015-004769-10

• Duration of Study in the UK

  1 years, 7 months, 23 days

• Research summary

  The name of this investigational new drug is GBR 900.

  This clinical research study is being sponsored by Glenmark Pharmaceuticals SA, Inc. Glenmark is developing GBR 900 in this clinical research study to treat acute or chronic pain in the joints (osteoarthritis). GBR 900 binds to TrkA thereby blocking the action of nerve growth factor (NGF) via this receptor. Information learned from the study may help other people with acute or chronic pain in the future.

  The purpose of this study is to see how safe and how well the body tolerates GBR 900, what the body does to GBR 900 (pharmacokinetics [PK]), including the effect of GBR 900’s analgesic (ability to relieve pain) and immunogenicity (ability to produce an immune response) properties, in adult patients with OA.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  16/LO/0688

• Date of REC Opinion

  25 Apr 2016

• REC opinion

  Unfavourable Opinion