Safety and PK Study of ALXN1830 IV in Healthy Adult Participants
Research type
Research Study
Full title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of Intravenous ALXN1830 in Healthy Participants.
IRAS ID
272563
Contact name
Ulrike Lorch
Contact email
Sponsor organisation
Alexion Pharma GmbH
Eudract number
2019-003557-28
Duration of Study in the UK
0 years, 9 months, 30 days
Research summary
We are conducting a clinical trial with the investigational drug ALXN1830. ALXN1830 is being developed by Alexion Pharmaceuticals, Inc.\n\nALXN1830 is a monoclonal antibody that blocks the recycling of immunoglobulin G (IgG) and IgG immune complexes (ICs), thereby lowering the circulating IgG (including pathogenic autoantibodies) and ICs. Current treatments for these diseases can be effective, but are associated with significant side effects and delayed or non-durable responses. It is hoped that ALXN1830 will have fewer side effects and a better response profile.\n\nThis study will evaluate the safety, tolerability, how the body processes ALXN1830 and immunogenicity of single ascending doses and multiple ascending doses of ALXN1830 administered intravenously, to Japanese and non-Japanese adult healthy volunteers. It will also evaluate the differences between Japanese and non-Japanese healthy participants.\n\nALXN1830 has been studied in 4 clinical trials to date (in patients and healthy volunteers), each of which used intravenous administration. ALXN1830 was generally well tolerated, with all adverse events being mild or moderate, and fully resolved after cessation of dosing.\n\n48 volunteers will participate in 6 cohorts, each containing 8 subjects. Cohorts 3b and 4b will enrol only Japanese participants. Within each cohort, volunteers will be randomly assigned to receive ALXN1830 or placebo, in a 6:2 ratio. Cohorts 1-2 will receive single ascending doses (30mg/kg and up to 60mg/kg respectively) and last up to 92 days. Cohorts 3a and 3b will receive 10mg/kg doses; three doses given weekly, followed by three doses given every other week; and last up to 148 days. Cohorts 4a and 4b will receive 20 or 30mg/kg doses; three doses given weekly, followed by three doses given every other week; and last up to 148 days.\n\nWe will assess safety parameters including physical examination, vital signs, laboratory evaluations, electrocardiograms and monitoring of adverse events.\n
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
19/SC/0508
Date of REC Opinion
13 Jan 2020
REC opinion
Further Information Favourable Opinion