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Clinical Trial of Comparative Study of GB221 Pharmacokinetics

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: NCT04175171
Recruitment Status : Completed
First Posted : November 22, 2019
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Genor Biopharma Co., Ltd.

Brief Summary:
The primary objective is to assess the safety of a single dose of GB221 compared to Herceptin® when administered as a single IV injection at a dose of 8 mg/kg. The secondary objective of the study is to assess the pharmacokinetics of GB221 compared to Herceptin®.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Coprelotamab Injection Drug: Trastuzumab Injection Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Parallel-group, Comparative Phase I Study to Evaluate the Safety and Pharmacokinetics of Single Intravenous (IV) Administration of GB221 Versus Herceptin® (Trastuzumab)
Actual Study Start Date : November 7, 2011
Actual Primary Completion Date : January 8, 2012
Actual Study Completion Date : March 8, 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Trastuzumab

Arm Intervention/treatment
Experimental: GB221
Coprelotamab Injection, 8mg/kg, single dose
Drug: Coprelotamab Injection
The single intravenous infusion of 8mg/kg Coprelotamab shall be administered within 90 minutes through infusion pump.
Other Name: GB221

Active Comparator: Herceptin
Trastuzumab Injection, 8mg/kg, single dose
Drug: Trastuzumab Injection
The single intravenous infusion of 8mg/kgTrastuzumab shall be administered within 90 minutes through infusion pump.
Other Name: Herceptin




Primary Outcome Measures :
  1. physical examination [ Time Frame: Up to 84 days ]
    physical examination

  2. adverse event [ Time Frame: Up to 84 days ]
    adverse event

  3. blood pressure [ Time Frame: Up to 84 days ]
    blood pressure

  4. heart rate [ Time Frame: Up to 84 days ]
    heart rate

  5. respiration rate [ Time Frame: Up to 84 days ]
    respiration rate

  6. oxygen saturation [ Time Frame: Up to 84 days ]
    oxygen saturation

  7. temperature [ Time Frame: Up to 84 days ]
    temperature


Secondary Outcome Measures :
  1. C max [ Time Frame: Up to 84 days ]
    C max

  2. t max [ Time Frame: Up to 84 days ]
    t max

  3. AUC [ Time Frame: Up to 84 days ]
    AUC

  4. CL [ Time Frame: Up to 84 days ]
    CL

  5. t ½ [ Time Frame: Up to 84 days ]
    t ½

  6. V [ Time Frame: Up to 84 days ]
    V



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

To be enrolled in the study, subjects must meet the following criteria

  1. Males aged 18 to 45 years.
  2. Healthy as judged by medical examination and medical history, and clinical chemistry and hematology screening.
  3. Body weight within the normal range for height (BMI between 19.0 and 29.0, inclusive) up to a maximum of 90 kg.
  4. Normal or non-clinically significant ECG.
  5. Normotensive (systolic: 90 - 140; diastolic: 50 - 90 mm Hg, inclusive) and heart rate (40 -100 bpm, inclusive).
  6. Willingness to give written and informed consent prior to any studyrelated procedures being conducted

Exclusion Criteria:

Subjects will be ineligible for the study if any of the following criteria apply:

  1. Receipt of any investigational agent or drug within 4 weeks of entry to the study.
  2. Use of any medicine - prescription, over-the-counter or herbal - in the 7 days prior to the treatment day and until 12 weeks after the treatment day.
  3. Donation of blood (or loss of blood) greater than 400 ml within 3 months of the study.
  4. Clinically significant drug allergy or sensitivity to any medication.
  5. A history of chronic or recurrent infections.
  6. A recent history of surgery.
  7. History or presence of malignancy (with the exception of successfully treated basal cell carcinoma).
  8. Inability to communicate or cooperate with the Principal Investigator because of English language difficulties or poor mental development.
  9. A history (within the last 5 years) or evidence of alcohol or drug abuse (excepting tobacco use less than 10 cigarettes per day).
  10. A positive urine test for drugs of abuse or alcohol either at screening or on the day of admittance for drug administration.
  11. Vaccination of any type within the previous month.
  12. A history of major psychiatric illness (such as bipolar disorder, schizophrenia or persistent major depression). Previous minor depression/adjustment disorder is acceptable if currently asymptomatic.
  13. Consumption of more than 3 standard drinks per day, and not able to abstain from alcohol totally within 24 hours of dose administration.
  14. Presence of current infection with tuberculosis, Hepatitis B, Hepatitis C or HIV.
  15. History of asthma or other chronic respiratory disease in the past 5 years.
  16. History of neurological or neuromuscular disease.
  17. History of hypertension or cardiovascular disease, including congestive heart failure and cardiomyopathy or a clinically significant echocardiogram finding at the screening visit.
  18. History of bladder or urethral disease.
  19. Smoking cigarettes > 10 per day.
  20. Any other condition which in the view of the Principal Investigator is likely to interfere with the study or put the subject at risk.

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): NCT04175171


Locations
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Australia, Western Australia
Linear Clinical Research Limited
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Genor Biopharma Co., Ltd.
Investigators
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Principal Investigator: Andrewn Redfer, PhD; MBBS Linear Clinical Research Limited
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Responsible Party: Genor Biopharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT04175171    
Other Study ID Numbers: GB221-001
First Posted: November 22, 2019    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents