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About
The purpose of this first-in-human study is to investigate the safety and tolerability of ABY-035 when administered intravenously and subcutaneously, to healthy volunteers and to psoriasis patients.
Full description
This first in human study with ABY-035 (a novel IL-17A inhibitor (interleukin 17A)) consists of four Parts. Part A consists of a single ascending intravenous dose study with 40 healthy volunteers divided into five dose cohorts. Each group consists of 8 subjects where 6 subjects will receive ABY-035 and 2 will receive placebo. The subjects will be followed for pharmacokinetic and safety assessments up to Day 95 after dosing.
Part B of the study consists of 6 healthy volunteers who will be given a single subcutaneous dose of ABY-035. The subjects will follow the same study visit schedule as Part A.
Part C of the study will include up to 12 moderate-to-severe psoriasis patients who each patient will be given a single intravenous dose of ABY-035. The patients will follow the same study visit schedule as Part A and B.
Part D of the study will include up to 18 psoriasis patients (mild, moderate or severe). Each patient will participate in 3 or 7 biweekly dosing occasions of subcutaneously administered ABY-035. Patients will be followed regularly for safety, efficacy and pharmacokinetics for 8 weeks post-final dose.
Enrollment
Sex
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Volunteers
Inclusion criteria
Part A, Part B
In addition for Part C and D
Exclusion criteria
Part A, Part B, Part C and Part D
In addition for Part C and D
Primary purpose
Allocation
Interventional model
Masking
72 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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