Safety, PK, and PD Study of ALXN1820 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 and Intravenous ALXN1820 in Healthy Participants
IRAS ID
300030
Contact name
Ulrike Lorch
Contact email
Sponsor organisation
Alexion Pharmaceuticals, Inc.
Eudract number
2021-002472-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Richmond is conducting a trial for a new drug called ALXN1820, to treat disorders of the immune system. ALXN1820 specifically works on the complement system which is a part of the immune system which helps to regulate the activity of other immune cells and proteins to fight infection. Although normally a beneficial part of the immune system it can leave human’s susceptible to disease when individual parts of the complement system are missing.
ALXN1820 is a bispecific antibody, meaning it is an antibody that binds two proteins (properdin and albumin) at the same time. Properdin binding is the main target of the medication while binding to albumin (a protein found in the blood) helps ALXN1820 stay in the bloodstream for longer. Properdin is a regulator of the complement system which when deficient increases the risk of meningococcal infection.
ALXN1820 can be given by subcutaneous injection, allowing administration at home. The main safety concern is an increased meningitis infection risk. The purpose of this study is to test the safety of ALXN1820, measure how the body processes ALXN1820 and measure how effective ALXN1820 is at reducing properdin levels.
Richmond is conducting cohorts 6 to 10 of a ten-cohort study. In each cohort, volunteers are randomly assigned to receive ALXN1820 or placebo in a 6:2 ratio. Cohorts 1-7 except for Cohort 5 will receive a single dose under the skin (ALXN1820 SC) while the Cohort 5 dose will be intravenous (ALXN1820 IV). Cohorts 1-7 are single dose. Cohorts 1 to 5 are ongoing in Australia. Richmond will conduct Cohorts 6,7, 8, 9 and 10. Cohorts 8 and 9 will both receive five doses, one week apart between each dose (ALXN1820 SC). Cohort 9 will only consist of Japanese healthy volunteers. Cohort 10 will receive a dose (to be determined) over three weeks.
REC name
London - London Bridge Research Ethics Committee
REC reference
21/LO/0385
Date of REC Opinion
27 Sep 2021
REC opinion
Further Information Favourable Opinion