Overview
This is a pilot study in healthy adult subjects to evaluate the safety and tolerability of AVT16 after administration of a single intravenous administration. Pharmacokinetics and immunogenicity of AVT16 will also be evaluated.
Eligibility
Inclusion Criteria:
- Healthy male and female subjects aged between 18 and 55 years old inclusive
- Medical history without evidence of clinically significant disorder, condition or disease that would pose a risk to subject safety
- Haematology and biochemistry tests within normal range
Exclusion Criteria:
- History of relevant drug and/or food allergies
- History of hypersensitivity to vedolizumab, AVT16 of their constituents
- Past or concurrent medical conditions that could potentially increase subject's risks or interfere with study evaluations