Clinical Trials Logo
  1. Home
  2. Healthy
  3. NCT06400719
  4. Details
NCT06400719 Clinical Trial

Pilot Study of AVT16 in Healthy Adult Subjects

Healthy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06400719
Other study ID # AVT16-GL-F01
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 29, 2024
Est. completion date October 16, 2024

Study information
Verified date May 2024
Source Alvotech Swiss AG
Contact Richard Bucknall
Phone 0041786598989
Email richard.bucknall@alvotech.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 18
Est. completion date October 16, 2024
Est. primary completion date October 16, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• AVT16
Single intravenous administration of 300mg of AVT16

Locations
Country Name City State
New Zealand CCST Christchurch

Sponsors (1)
Lead Sponsor Collaborator
Alvotech Swiss AG

Country where clinical trial is conducted

New Zealand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence, nature and severity of Treatment Emergent Adverse Events Safety and Tolerability of AVT16 18 weeks
Secondary Maximum Plasma Concentration (Cmax) of AVT16 Pharmacokinetic parameters 18 weeks
Secondary Frequency of anti-drug antibodies Immunogenicity of AVT16 18 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1