Pilot Study of AVT16 in Healthy Adult Subjects
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
1 other identifier
interventional
18
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started May 2024
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2024
CompletedFirst Posted
Study publicly available on registry
May 6, 2024
CompletedStudy Start
First participant enrolled
May 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2024
CompletedMarch 11, 2025
March 1, 2025
5 months
April 24, 2024
March 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence, nature and severity of Treatment Emergent Adverse Events
Safety and Tolerability of AVT16
18 weeks
Secondary Outcomes (2)
Maximum Plasma Concentration (Cmax) of AVT16
18 weeks
Frequency of anti-drug antibodies
18 weeks
Study Arms (1)
AVT16
EXPERIMENTALSingle intravenous administration of 300mg AVT16, proposed biosimilar to vedolizumab
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CCST
Christchurch, 8011, New Zealand
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2024
First Posted
May 6, 2024
Study Start
May 29, 2024
Primary Completion
November 6, 2024
Study Completion
November 6, 2024
Last Updated
March 11, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share