Pilot Study of AVT16 in Healthy Adult Subjects
- Registration Number
- NCT06400719
- Lead Sponsor
- Alvotech Swiss AG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AVT16 AVT16 Single intravenous administration of 300mg AVT16, proposed biosimilar to vedolizumab
- Primary Outcome Measures
Name Time Method Incidence, nature and severity of Treatment Emergent Adverse Events 18 weeks Safety and Tolerability of AVT16
- Secondary Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax) of AVT16 18 weeks Pharmacokinetic parameters
Frequency of anti-drug antibodies 18 weeks Immunogenicity of AVT16
Trial Locations
- Locations (1)
CCST
🇳🇿Christchurch, New Zealand