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NCT06400719 | COMPLETED | Healthy

Pilot Study of AVT16 in Healthy Adult Subjects
Sponsor:

Alvotech Swiss AG

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.

Condition or disease

Healthy

Intervention/treatment

AVT16

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 18 participants
Masking : NONE
Primary Purpose : TREATMENT
Official 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
Actual Study Start Date : 2024-05-29
Estimated Primary Completion Date : 2024-11-06
Estimated Study Completion Date : 2024-11-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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
Pilot Study of AVT16 in Healthy Adult Subjects

Location Details

NCT06400719

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

New Zealand,

CCST

Christchurch, New Zealand, 8011