Open label, randomised, pharmacokinetic study of ligelizumab
Research type
Research Study
Full title
An open-label, randomized, parallel-group, comparative pharmacokinetic study of ligelizumab administered as liquid-in-vial formulation (LIVI) or via a prefilled syringe (PFS)
IRAS ID
288963
Contact name
Krizzia Rairata
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2020-002817-17
Duration of Study in the UK
0 years, 5 months, 4 days
Research summary
This is an open-label, randomised, parallel-group study with the study drug, ligelizumab, to be performed at a single clinical centre. Ligelizumab is under development by Novartis for the treatment of chronic spontaneous urticaria (CSU) (hives), which is a tormenting skin condition characterised by itchy or burning wheals, blisters or redness.
This is not a first-in-human study. In previous clinical trials, an injection solution of ligelizumab from a vial was injected under the skin (subcutaneous [s.c.]) with a conventional syringe and needle. Novartis has now developed a ready-to-use syringe containing the ligelizumab injection solution. This study will compare the pharmacokinetics (PK) of ligelizumab when administered once with a pre-filled syringe in one treatment group and once with an injection solution from a vial in the other treatment group. Pharmacokinetics refers to how the study drug is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body). The further aims of this study are to assess safety and tolerability of single doses of ligelizumab and the effect of ligelizumab on the body. Following optional sample collection, pharmacogenomics will be investigated to gain better understanding of specific hereditary factors that may affect ligelizumab safety and chemical break down.
The study comprises a screening visit, a baseline assessment, a single treatment day (Day 1), a follow-up period of about 98 days, and an end-of-study assessment at about 125 days after administration of the study drug. After dosing on Day 1, the subjects will remain in-house for 48 hours until Day 3 assessments are completed. After discharge, subjects will be required to return for outpatient visits.
A total of about 132 healthy male and female subjects are planned to be enrolled with 66 participants in each treatment group. Female subjects must be of non-childbearing potential. The study has already started in the USA and 35 participants have already been enrolled.
REC name
London - Brent Research Ethics Committee
REC reference
20/LO/1074
Date of REC Opinion
30 Oct 2020
REC opinion
Further Information Favourable Opinion