Healthy
Conditions
Brief summary
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.
Interventions
BIOLOGICALAVT16
Single intravenous administration of 300mg of AVT16
Sponsors
Alvotech Swiss AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence, nature and severity of Treatment Emergent Adverse Events | 18 weeks | Safety and Tolerability of AVT16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of AVT16 | 18 weeks | Pharmacokinetic parameters |
| Frequency of anti-drug antibodies | 18 weeks | Immunogenicity of AVT16 |
Countries
New Zealand
Outcome results
None listed