CT-P17 – first doses in humans & comparison with Humira; v1
Research type
Research Study
Full title
A pilot phase 1, randomised, double-blind, two-arm, parallel group, single-dose study to evaluate the safety and pharmacokinetics of CT-P17 and Humira in healthy male subjects (HMR code: 18-008)
IRAS ID
250717
Contact name
Malcolm Boyce
Contact email
Sponsor organisation
CELLTRION, Inc.
Eudract number
2018-002475-17
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
CT P17 (the study medicine) is an experimental treatment for autoimmune (AI) diseases (such as rheumatoid arthritis, Crohn’s disease or psoriasis) in which the body attacks its own tissues. Normally, the immune system helps protect the body from harmful substances, such as bacteria or viruses. But, in patients with AI diseases, the immune system can’t tell the difference between healthy body tissues and harmful substances, so it attacks and destroys normal body tissues. We hope that CT-P17 will stop the immune system doing that by blocking a substance called TNF–alpha, which is involved in the ‘immune response’ (how the body recognises and defends itself against infection by bacteria, viruses, and substances that appear foreign and harmful). CT P17 is a large protein called a ‘monoclonal antibody’.\n\nCT-P17 hasn’t been given to humans before, but it’s a new form of an existing medicine called Humira (adalimumab), which is prescribed by doctors to treat AI diseases. CT-P17 is being developed as a ‘biosimilar’ medicine to Humira, which means that it contains a similar antibody as Humira. We’re doing this study to compare side effects and blood levels of CT-P17 and Humira, and find out if the body makes antibodies against each medicine. \n\nWe’ll give 30 healthy men, aged 18–55 years, a single dose of either the study medicine or Humira, by injection under the skin. \n\nParticipants will take up to 14 weeks to finish the study. They’ll stay on the ward for 7 nights in a row, and they’ll make 8 outpatient visits.\n\nA pharmaceutical company (CELLTRION, Inc.) is funding the study.\n\nThe study will take place at 1 centre in London.
REC name
HSC REC A
REC reference
18/NI/0140
Date of REC Opinion
4 Sep 2018
REC opinion
Further Information Favourable Opinion