Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
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
Layout table for investigator information
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

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
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

Layout table for additional information
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:
Layout table for MeSH terms
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors