Pilot Study of AVT16 in Healthy Adult Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-29

Study Completion Date

2024-11-06

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AVT16

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

Group Type EXPERIMENTAL

AVT16

Intervention Type BIOLOGICAL

Single intravenous administration of 300mg of AVT16

Interventions

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AVT16

Single intravenous administration of 300mg of AVT16

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes