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Study of Bevacizumab(BAT1706) and Comparators in Healthy Subjects

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: NCT03030430
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Bio-Thera Solutions

Brief Summary:
The purpose of this study is to establish PK similarity in the treatment of BAT1706 and comparators.

Condition or disease Intervention/treatment Phase
NSCLC Biological: BAT1706 injection Biological: EU-sourced Avastin Biological: US-sourced Avastin Phase 1

Detailed Description:

This is a Phase I, randomized, double-blind, single-dose, 3-arm parallel group study to compare the PK, and to evaluate the safety, tolerability and immunogenicity, of BAT1706, EU-Avastin and US-Avastin after a single IV infusion in healthy adult male subjects.

A total of 129 healthy male subjects who meet the required entry criteria will be randomly assigned to one of three treatment groups in a 1:1:1 ratio to receive a single IV infusion of either BAT1706, EU-Avastin or US-Avastin. A total of 117 evaluable subjects are required.

Initially, subjects will be administered the study drug in staggered groups; the first group will comprise 3 subjects, the second group 6 subjects and the third group 9 subjects. Within each group subjects will be randomized to ensure equal numbers of subjects receive each of the three treatments.

There will be at least 48 hours between administrations of study drug to each group. Prior to administration of study drug to the next group, the safety and tolerability findings of the preceding group will be reviewed by the Principal Investigator. The next group will be dosed provided there are no serious or unexpected drug-related safety issues. Each subject will be required to remain in the clinical center for 48 hours after dosing for safety evaluation.

After the first 3 groups have been evaluated, the Principal Investigator will decide whether to proceed with continuous enrolment according to the clinical center capability.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Single-dose, 3-arm Parallel Design Comparative Pharmacokinetic(PK) and Safety Study of BAT1706 Versus European Union(EU)-Sourced Avastin® and United State (US)-Sourced Avastin® Administered in Healthy Subjects
Actual Study Start Date : March 15, 2016
Actual Primary Completion Date : May 16, 2017
Actual Study Completion Date : June 28, 2017

Arm Intervention/treatment
Experimental: BAT1706
BAT1706 injection
Biological: BAT1706 injection
1mg/kg, IV on day 1

Active Comparator: EU-sourced Avastin
EU-sourced Avastin
Biological: EU-sourced Avastin
1mg/kg, IV on day 1

Active Comparator: US-sourced Avastin
US-sourced Avastin
Biological: US-sourced Avastin
1mg/kg, IV on day 1




Primary Outcome Measures :
  1. area under curve (AUC)0~∞ [ Time Frame: 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Adult males aged 18 to 50 years inclusive and body weight 65 to 100kg.
  2. Subjects who are healthy as determined by pre-study medical history, physical examination, vital signs and 12 ECG.
  3. Subjects whose clinical laboratory test results are normal, or where outside the reference range are judged as not clinical relevant.

Exclusion Criteria:

  1. Have a history of and/or current clinically significant gastrointestinal, renal, hepatic, cardiovascular, haematological, pulmonary, neurologic, metabolic, psychiatric or allergic disease excluding mild asymptomatic seasonal allergies.
  2. Subject with a psychiatric disorder or considered unsuitable for inclusion by the investigator.
  3. History or current clinically significant, excluding mild asymptomatic seasonal allergies, hypersensitivity or allergic reactions including known or suspected drug hypersensitivity to any component of the study drug formulations or comparable drugs.
  4. Any biological drug within 3 months or monoclonal antibodies within 9 months of study drug administration.
  5. Intake of herbal remedies within 14 days prior to study drug administration.
  6. History of alcohol abuse or a positive alcohol test on screening or admission to the clinical center.
  7. Any persons who are:an employee of the Principal Investigator, clinical center, Clinical Research Organization (CRO) or Sponsor;a relative of an employee of the clinical center, the Investigators, CRO or the Sponsor.

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): NCT03030430


Locations
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New Zealand
Christchurch Clinical Studies Trust Ltd (CCST)
Christchurch, New Zealand, 8011
Sponsors and Collaborators
Bio-Thera Solutions
Investigators
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Principal Investigator: Chris Wynne, Medical Doc Director
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bio-Thera Solutions
ClinicalTrials.gov Identifier: NCT03030430    
Other Study ID Numbers: BAT-1706-001
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018
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