GSK4527363 – First Time in Human Study

• Research type

  Research Study

• Full title

  A Phase 1, first-time-in-human, three-part study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of GSK4527363 in healthy participants (Part A), participants with active systemic lupus erythematosus (Part B), and healthy participants of Chinese and Japanese descent (Part C).

• IRAS ID

  1010205

• Contact name

  N/A

• Contact email

  GSKClinicalSupportHD@gsk.com

• Sponsor organisation

  GlaxoSmithKline Research & Development Limited

• Eudract number

  2024-514186-18

• Clinicaltrials.gov Identifier

  NCT06576271

• Research summary

  Lupus is a lifelong autoimmune disease in which the body’s immune system mistakenly attacks healthy tissue, causing inflammation and damage. It can affect almost any organ in the body and is thought to involve a type of white blood cell called B cells. GSK is developing a drug (GSK4527363) for the treatment of lupus.
  GSK4527363 is a monoclonal antibody (a type of protein) that works by recognizing and attaching to a specific target in the body. It is expected that GSK4527363 will reduce the number of B cells in the blood.
  This study is the first time that GSK4527363 will be given to humans. It has only been tested on animals and in the laboratory. The study will test single and repeat doses of GSK4527363 to assess its side effects, blood levels, effects on the immune system, and whether the body makes antibodies against it.
  The study is in 3-parts.
  Part A will test single doses of GSK4527363 or belimumab (another drug approved for treating lupus) in healthy men and women of non-childbearing potential, aged 18–55.
  Part B will test repeated doses of GSK4527363 or belimumab in men and women with lupus, aged 18–65.
  Part C will test single doses of GSK4527363 in healthy men and women of non-childbearing potential of Japanese or Chinese decent, aged 18–55.
  Study participants in Parts A and C will not benefit directly, but patients in Part B may have some short-term medical benefit. All participants may help GSK to develop a new drug for an unmet need in lupus.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  24/SC/0192

• Date of REC Opinion

  14 Aug 2024

• REC opinion

  Further Information Favourable Opinion