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OpenTrials
Completed

NCT Number: NCT06400719

Pilot Study of AVT16 in Healthy Adult Subjects

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CCST

Christchurch, 8011, New Zealand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AVT16

Biological

Single intravenous administration of 300mg of AVT16

Primary outcomes

  1. Incidence, nature and severity of Treatment Emergent Adverse Events

    Time frame: 18 weeks

    Safety and Tolerability of AVT16

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax) of AVT16

    Time frame: 18 weeks

    Pharmacokinetic parameters

  2. Frequency of anti-drug antibodies

    Time frame: 18 weeks

    Immunogenicity of AVT16

Sponsors and collaborators

Lead sponsor

Alvotech Swiss AG

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 6, 2024
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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