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Completed

NCT Number: NCT03247673

To Demonstrate Similarity of Pharmacokinetics and Evaluate Safety of CT-P16, EU-Approved Avastin and US-licensed Avastin

This study is a Phase 1 Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to compare the PK, safety and immunogenicity of the proposed biosimilar test product CT-P16 with EU-approved Avastin and US-licensed Avastin after a single IV infusion of 5mg/kg of each product to healthy male subjects

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Key information

Conditions

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Inje University Busan Paik Hospital, Busan, South Korea

Loading trial locations.

About this study

This study is a double-blind, three-arm, parallel group, single-dose study. A total of 141 subjects will be enrolled; 47 subjects in each of the 3 arms of the clinical study. In each arm, all subjects will receive a single dose (5 mg/kg) of either CT-P16, EU-approved Avastin, or US-licensed Avastin by intravenous (IV) infusion for 90 min (±5 min) on Day 1 followed by 15 weeks during which the PK, safety, and immunogenicity measurements will be made. The randomization will be stratified by body weight and site.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male subjects between the ages of 19 and 55 years, both inclusive
  • Body Mass Index (BMI) between 18.0 and 29.9 kg/m2 (both inclusive) and a body weight ≥ 50 kg

Exclusion criteria

  • Subject is a female.
  • Clinically significant allergic reactions, hypersensitivity
  • A disease classed as significant by the Investigator
  • Non-healing wound, ulcer, bone fracture, a major surgical procedure, significant traumatic injury
  • Any malignancy
  • Undergone treatment with an investigational drug or participated in another clinical trial
  • Plans to father a child or donates sperms

Treatment and study plan

CT-P16

Drug

CT-P16 is a biosimilar product for Avastin

Other names: bevacizumab

EU-approved Avastin

Drug

EU-approved Avastin

Other names: bevacizumab

US-licensed Avastin

Drug

US-licensed Avastin

Other names: bevacizumab

Primary outcomes

  1. AUC0-inf

    Time frame: pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI

    Area under the concentration-time curve from time zero to infinity

  2. Cmax

    Time frame: pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI

    Maximum Serum Concentration (Cmax)

  3. AUC0-last

    Time frame: pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI

    Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration

Secondary outcomes

  1. Additional Pharmacokinetics (Time to Cmax)

    Time frame: pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI

    To assess the additional PK of study drugs (Time to Cmax)

  2. Number of Participants With Anti-Drug Antibody Positive

    Time frame: up to 15 weeks

    number of participants with anti-drug antibody positive at post-dose

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study title

A Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Bevacizumab (CT-P16, EU-approved Avastin and US-licensed Avastin) in Healthy Male Subjects

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Aug 14, 2017
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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