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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04744363
Other study ID # AVT04-GL-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 25, 2021
Est. completion date March 19, 2022

Study information

Verified date May 2022
Source Alvotech Swiss AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Protocol Title: A Phase 1, first-in-human, randomized, double-blind, single-dose, parallel-group, 3-arm study comparing the pharmacokinetic, safety, tolerability, and immunogenicity profiles of AVT04, EU approved Stelara®, and US-licensed Stelara® in healthy adult subjects Short Title: A first-in-human randomized, double-blind study to compare AVT04 with EU-approved Stelara and US-licensed Stelara as a single-dose subcutaneous injection in healthy adult subjects Rationale: Alvotech (hereafter, the Sponsor) is developing AVT04 globally as a proposed biosimilar to the reference product Stelara (ustekinumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT04. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed biosimilar test product AVT04 and the reference products EU approved Stelara and US-licensed Stelara, in addition to evaluating the safety and tolerability of AVT04, when administered as a single 45 mg/0.5 mL SC dose.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Stelara PFS
Pre filled syringes filled with AVT04 and Stelara

Locations

Country Name City State
Australia Nucleus Network Brisbane
Australia Nucleus Network Melbourne Melbourne
New Zealand ACS Auckland
New Zealand CCST Christchurch

Sponsors (2)

Lead Sponsor Collaborator
Alvotech Swiss AG Iqvia Pty Ltd

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Other The inflammatory cytokine biomarkers to be assessed include: IFN-?, IL-22, IL-17, IL-5, IL-13, and IL-10 Venous blood samples will be collected to assess the cytokine biomarkers From screening to day 92
Primary Area under the plasma concentration-time curve AUC0-inf Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUC 0-t) of AVT04, US Stelara EU Stelara From Baseline to day 92
Primary Maximum serum concentration Venous blood samples will be collected for measurement of serum concentration of AVT04, EU Stelara, US Stelara From Baseline to day 92
Secondary Ustekinumab serum concentration-time profile following single-dose administration Venous blood samples will be collected for measurement of serum concentration time profile of AVT04, US-Stelara EU Stelara From Baseline to day 92
Secondary The secondary PK parameters to be assessed are: AUC0-t Venous blood samples will be collected for measurement of the title measures of AVT04, US-Stelara EU Stelara From Baseline to day 92
Secondary Adverse Events The safety parameters to be assessed include AEs, clinical laboratory assessments (hematology, clinical chemistry, coagulation, urinalysis and urine microscopy), vital signs, ECG, physical examination findings, and injection site reactions From screening to day 92
Secondary Immunogenicity assessments include ADAs and NAbs Formation of neutralizing antibodies measured through a validated system From screening to day 92
Secondary The secondary PK parameters to be assessed are: Tmax Venous blood samples will be collected for measurement of the title measures of AVT04, US-Stelara EU Stelara From screening to day 92
Secondary The secondary PK parameters to be assessed are: Kel Venous blood samples will be collected for measurement of the title measures of AVT04, US-Stelara EU Stelara From Screening to day 92
Secondary The secondary PK parameters to be assessed are: t1/2 Venous blood samples will be collected for measurement of the title measures of AVT04, US-Stelara EU Stelara From Screening to day 92
Secondary The secondary PK parameters to be assessed are: Vz/F Venous blood samples will be collected for measurement of the title measures of AVT04, US-Stelara EU Stelara From screening to day 92
Secondary The secondary PK parameters to be assessed are: CL/F Venous blood samples will be collected for measurement of the title measures of AVT04, US-Stelara EU Stelara From Screening to day 92
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