ABY-035 - Phase I study in healthy subjects and psoriasis patients
Research type
Research Study
Full title
A Phase I, Partially Randomised, Partially Double blinded, Single Dose, Safety, Tolerability, and Pharmacokinetic Study of ABY-035 in Healthy Subjects and Psoriasis Patients
IRAS ID
194347
Contact name
Sunu Valasseri
Contact email
Sponsor organisation
Affibody AB
Eudract number
2015-004531-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
ABY-035 is a novel molecule, which is being developed with an aim to help people with psoriasis. ABY-035 acts by blocking interleukin IL-17A. IL-17A is thought to play part in the psoriasis disease process. There is already one licenced drug on the market with similar mechanism of action, ABY-035 is thought to be more potent than this drug. ABY-035 has not been tested in man. Tests in animals did not raise any significant safety concerns.\n\nThe main purpose of this first in human study is to assess the safety and tolerability when it is given as an IV (intravenous) injection. The other objectives include relative availability of the drug when it is given as a subcutaneous (below the skin) injection and also to assess the clinical efficacy in psoriasis patients after an IV dose.\n\nThis study will be conducted in three parts. Part A will be a single dose study, starting with a low dose and subsequent groups getting a higher dose. There will be 5 groups in this part. The first two subjects in each group will be dosed 48 hours before the rest of the group. The drug will be administered as an IV infusion. Each group will have 8 volunteers of which two will receive dummy drug. In part B a single dose will be administered as a subcutaneous injection to six volunteers. Part C will investigate clinical efficacy in psoriasis patients after an IV dose.\n\nThis study includes both males and females between the ages 18-65. The subjects will have to comply with contraceptive requirement of the study. Subjects are required to check in the day before dosing and will be followed up until day 95 after the drug administration.
REC name
North East - York Research Ethics Committee
REC reference
15/NE/0389
Date of REC Opinion
11 Jan 2016
REC opinion
Further Information Favourable Opinion