Safety and PK Study of SC ALXN1830 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 Subcutaneous ALXN1830 in Healthy Participants
IRAS ID
272411
Contact name
Ulrike Lorch
Contact email
Sponsor organisation
Alexion Pharma GmbH
Eudract number
2019-003496-18
Duration of Study in the UK
0 years, 10 months, 7 days
Research summary
We are conducting a clinical trial with the investigational drug ALXN1830. ALXN1830 is being developed by Alexion Pharmaceuticals, Inc.\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. Certain autoimmune diseases can be mediated by pathogenic circulating IgG and 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.\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 subcutaneously, to healthy adult volunteers.\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.\nUp to 56 volunteers will participate in up to 7 cohorts, each containing 8 participants. Within each cohort, volunteers will be randomly assigned to receive ALXN1830 or placebo, in a 6:2 ratio. Cohorts 1-3 will receive single ascending doses (750mg, 1500mg and 2250mg respectively) and last up to 64 days. Cohort 4 will receive twice weekly doses (300mg), for a total of 8 doses and last up to 88 days. Cohort 5 will receive weekly doses (750mg), for a total of 12 doses and last up to 141 days. Cohorts 6 and 7 will receive weekly doses (1500mg and 1500-2250mg respectively) for a total for 4 doses and last up to 88 days. Cohort 7 is optional.\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/0495
Date of REC Opinion
29 Oct 2019
REC opinion
Further Information Favourable Opinion