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NCT06400719 Clinical Trial

Pilot Study of AVT16 in Healthy Adult Subjects

Healthy Clinical Trial

Official title:
An Open Label, Single Arm Pilot Study to Investigate the Safety and Tolerability of a Single 300mg Intravenous Dose of AVT16 in Healthy Adult Subjects Aged 18 to 55 Years Inclusive

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06400719
Other study ID # AVT16-GL-F01
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 29, 2024
Est. completion date October 16, 2024

Study information
Verified date May 2024
Source Alvotech Swiss AG
Contact Richard Bucknall
Phone 0041786598989
Email richard.bucknall@alvotech.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 18
Est. completion date October 16, 2024
Est. primary completion date October 16, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• AVT16
Single intravenous administration of 300mg of AVT16

Locations
Country Name City State
New Zealand CCST Christchurch

Sponsors (1)
Lead Sponsor Collaborator
Alvotech Swiss AG

Country where clinical trial is conducted

New Zealand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence, nature and severity of Treatment Emergent Adverse Events Safety and Tolerability of AVT16 18 weeks
Secondary Maximum Plasma Concentration (Cmax) of AVT16 Pharmacokinetic parameters 18 weeks
Secondary Frequency of anti-drug antibodies Immunogenicity of AVT16 18 weeks
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