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Pilot Study of AVT16 in Healthy Adult Subjects

Not Recruiting
18 - 55 years of age
Both
Phase 1

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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

Study details

Healthy

NCT06400719

Alvotech Swiss AG

20 January 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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