Pilot Study of AVT16 in Healthy Adult Subjects

Alvotech

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: AVT16

Study type: Interventional

Funder types: Industry

Identifiers

NCT06400719

AVT16-GL-F01

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

AVT16

Experimental group

Description:

Single intravenous administration of 300mg AVT16, proposed biosimilar to vedolizumab

Treatment:

Biological: AVT16