*FIH study of ALXN2080 in healthy participants
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled First-in-Human Study of Single and Multiple Doses of ALXN2080 in Healthy Participants
IRAS ID
1005547
Contact name
Manjula Dundoo
Contact email
Sponsor organisation
Alexion Pharmaceuticals, Inc.
Eudract number
2022-000555-36
Clinicaltrials.gov Identifier
Research summary
ALXN2080 is a new investigational molecule being developed by Alexion Pharmaceuticals for the potential treatment of diseases arising due to dysregulation or overactivation of a component of the immune system called Complement pathway. Complement system is a part of the innate immune system that comprises a highly complex network of mediators that together enhance (hence the word 'Complement') the ability of antibodies and phagocytic cells to fight microbes. In some instances, the complement activation could be inappropriately excessive which could result in unwanted damage to the host body. ALXN2080 is considered as potentially beneficial in containing the overly stimulated complement-mediated immune response. In that sense, it is thought to be in principle similar to anti-inflammatory drugs with the only difference being a totally different mechanism of action compared to regular anti-inflammatory drugs.
In the proposed study ALXN2080 will be studied for the first time in humans. Single, ascending doses of the study drug will be administered to 6 groups of healthy volunteers (each group 10 participants) so that a total of 60 participants will be studied.
Following a review of the safety data the next part of the study will be initiated where multiple doses of ALXN2080 will be administered in 40 healthy volunteers (4 groups of 10 volunteers). Each participant will receive daily dosing for a total of 14 days. There will be a safety review after completion of each dose level before proceeding to the next higher level of dose. Evaluation of the safety of the ALXN2080 will be done by various clinical assessments that include monitoring for adverse events, blood tests, ECG, Urine tests and blood pressure measurements.
The primary objective of the study is to assess the safety and tolerability of ALXN2080 in heathy volunteers.
The secondary objective will be to measure the blood concentrations of ALXN2080 after oral administration.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
22/FT/0072
Date of REC Opinion
11 Jul 2022
REC opinion
Further Information Favourable Opinion