Pilot Study of AVT16 in Healthy Adult Subjects

March 10, 2025 updated by: Alvotech Swiss AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AVT16
Single intravenous administration of 300mg AVT16, proposed biosimilar to vedolizumab
Biological: AVT16
Single intravenous administration of 300mg of AVT16

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence, nature and severity of Treatment Emergent Adverse Events
Time Frame: 18 weeks
Safety and Tolerability of AVT16
18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Plasma Concentration (Cmax) of AVT16
Time Frame: 18 weeks
Pharmacokinetic parameters
18 weeks
Frequency of anti-drug antibodies
Time Frame: 18 weeks
Immunogenicity of AVT16
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alvotech Swiss AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2024

Primary Completion (Actual)

November 6, 2024

Study Completion (Actual)

November 6, 2024

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • AVT16-GL-F01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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