Safety, Tolerability and PK of ABY-039 in Healthy Volunteers
Research type
Research Study
Full title
A PHASE I, FIRST-IN-HUMAN, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SAFETY, TOLERABILITY AND PHARMACOKINETIC STUDY OF ABY-039 IN HEALTHY SUBJECTS
IRAS ID
232715
Contact name
Muna Albayaty
Contact email
Sponsor organisation
Affibody AB
Eudract number
2017-002918-32
Duration of Study in the UK
0 years, 10 months, 2 days
Research summary
This is a phase 1, first-in-human, randomized, double-blind, placebo-controlled clinical study in healthy volunteers, which will be conducted in 2 parts (Part A and Part B):\n\nPart A will be a single ascending doses (IV and subcutaneous administration) part in healthy volunteers.\n\nAn interim analysis of the safety data from part A will be performed before proceeding to part B.\n\nPart B is a multiple ascending dose part(subcutaneous administration) in healthy volunteers. \n\nThis study is the first time that ABY-039 will be given to human participants. ABY-039 is a new drug being developed by Affibody AB. Affibody is developing the drug for the treatment of autoimmune diseases such as chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a disease where the body’s immune system causes damage to the nerves that connect the brain and spinal cord to the muscles in the arms and legs.\n\nThe main purpose of the study is to see how safe the drug is and how well the body tolerates the drug after single and multiple doses are administered to healthy male and female participants. The study will also look at how the drug is absorbed (taken up into the body), metabolised (chemically broken down), and distributed through the body. A further aim is to look at the effect of the study drug on ABY-039 on the concentration of antibody in the blood.
REC name
London - Hampstead Research Ethics Committee
REC reference
17/LO/1951
Date of REC Opinion
19 Jan 2018
REC opinion
Further Information Favourable Opinion