Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of ALXN2030 in Healthy Participants
Research type
Research Study
Full title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Subcutaneous ALXN2030 in Healthy Participants
IRAS ID
1005384
Contact name
Raja Veerasingham
Contact email
Sponsor organisation
Alexion Pharmaceuticals, Inc.
Eudract number
2022-000425-24
Clinicaltrials.gov Identifier
Research summary
This is a first-time-in-human clinical trial. The new medicine tested in this clinical trial is a compound called ALXN2030. Alexion Pharmaceuticals, Inc. is developing the clinical trial medicine for treating disease states that involve poor regulation of a part of the immune system, called the complement system. The complement system comprises a large number of proteins in the blood that react with one another and induce inflammatory responses; usually this is to fight infections but sometimes the complement system becomes uncontrolled, and this may lead to a disease state. Such a disease state can occur after kidney transplantation leading to rejection of the transplant (chronic antibody-mediated rejection [cAMR]) for which a specific treatment so far is not yet available.\n\nThe main purpose of the clinical trial is to see how safe the clinical trial medicine is and how well it is tolerated after dosing. \nThis clinical trial will recruit healthy males and females (including Japanese participants) between the ages of 18 and 60 years (20 and 60 years for Japanese participants). A total of up to approximately 48 participants will take part in the clinical trial, of which 8 will be Japanese. Japanese and non-Japanese participants are included in this clinical trial to evaluate the potential impact of ethnic factors as different races often break down drugs differently. This will be evaluated by comparing these two populations. In addition, the information that we get from this clinical trial may be helpful in treating Japanese and other patients with a poorly dysregulated part of the immune system in the future. \nThe clinical trial is divided into 6 dosing groups. Separate groups of participants will be included in each dosing group of the clinical trial. There will be 8 participants assigned to each dosing group.
REC name
London - Brent Research Ethics Committee
REC reference
22/LO/0295
Date of REC Opinion
5 May 2022
REC opinion
Favourable Opinion