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

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ClinicalTrials.gov Identifier: NCT03247673
Recruitment Status : Completed
First Posted : August 14, 2017
Results First Posted : July 25, 2019
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Celltrion

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Healthy Drug: CT-P16 Drug: EU-approved Avastin Drug: US-licensed Avastin Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official 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
Actual Study Start Date : August 7, 2017
Actual Primary Completion Date : December 22, 2017
Actual Study Completion Date : January 17, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: CT-P16
CT-P16 will be administrated once in IV infusion of 5mg/KG to healthy male subjects
Drug: CT-P16
CT-P16 is a biosimilar product for Avastin
Other Name: bevacizumab

Active Comparator: EU-approved Avastin
EU-approved Avastin will be administrated once in IV infusion of 5mg/KG to healthy male subjects
Drug: EU-approved Avastin
EU-approved Avastin
Other Name: bevacizumab

Active Comparator: US-licensed Avastin
US-licensed Avastin will be administrated once in IV infusion of 5mg/KG to healthy male subjects
Drug: US-licensed Avastin
US-licensed Avastin
Other Name: bevacizumab




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03247673


Locations
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Korea, Republic of
Inje University Busan Paik Hospital
Busan, Korea, Republic of
Inha University Hospital
Incheon, Korea, Republic of
Seoul St.Mary's hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Celltrion
Investigators
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Study Director: Sung Young Lee Celltrion
  Study Documents (Full-Text)

Documents provided by Celltrion:
Statistical Analysis Plan  [PDF] March 29, 2018
Study Protocol  [PDF] June 7, 2017

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT03247673    
Other Study ID Numbers: CT-P16 1.1
First Posted: August 14, 2017    Key Record Dates
Results First Posted: July 25, 2019
Last Update Posted: March 26, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celltrion:
safety
Pharmacokinetics
Immunogenicity
Additional relevant MeSH terms:
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Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors