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A Comparing Study Between ALT02(Trastuzumab Biosimilar) and Herceptin® 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: NCT03242239
Recruitment Status : Completed
First Posted : August 8, 2017
Last Update Posted : August 21, 2017
Sponsor:
Collaborator:
Cristália Produtos Químicos Farmacêuticos Ltda.
Information provided by (Responsible Party):
Alteogen, Inc.

Tracking Information
First Submitted Date  ICMJE August 2, 2017
First Posted Date  ICMJE August 8, 2017
Last Update Posted Date August 21, 2017
Actual Study Start Date  ICMJE February 9, 2016
Actual Primary Completion Date August 4, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2017)
AUC0-inf: area under the concentration-time curve from time zero to infinity [ Time Frame: 43 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2017)
  • AUC0-t: area under the concentration-time curve from time zero to the last non-zero concentration [ Time Frame: 43 days ]
  • Cmax: maximum observed concentration [ Time Frame: 43 days ]
  • Tmax: time of observed Cmax [ Time Frame: 43 days ]
  • Kel: apparent terminal elimination rate constant [ Time Frame: 43 days ]
  • T½ el: apparent terminal half-life [ Time Frame: 43 days ]
  • CL: apparent body clearance, calculated as Dose/AUC0-inf [ Time Frame: 43 days ]
  • Vd: apparent volume of distribution, calculated as Dose/(kel x AUC0-inf) [ Time Frame: 43 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparing Study Between ALT02(Trastuzumab Biosimilar) and Herceptin® in Healthy Subjects
Official Title  ICMJE A Randomized, Double-Blind, Parallel, Phase I Pharmacokinetic Trial Comparing The Potential Biosimilar ALT02(Trastuzumab) With Herceptin in Healthy Volunteers
Brief Summary The purpose of this study is to compare ALT02 (Trastuzumab biosimilar) and Herceptin® (US-licensed Trastuzumab and EU-licensed Trastuzumab) in healthy male subjects about the pharmacokinetics, safety, tolerability and immunogenicity.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: ALT02
  • Biological: EU-licensed Herceptin
  • Biological: US-licensed Herceptin
Study Arms  ICMJE
  • Experimental: ALT02
    Intervention: Biological: ALT02
  • Active Comparator: EU-licensed Herceptin
    Intervention: Biological: EU-licensed Herceptin
  • Active Comparator: US-licensed Herceptin
    Intervention: Biological: US-licensed Herceptin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 3, 2017)
105
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 30, 2016
Actual Primary Completion Date August 4, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male subjects
  • Have a body weight over 50.0 kg and a body mass index over than 18.5 and less than 30.0 kg/m², inclusive.

Exclusion Criteria:

  • Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
  • Positive urine drug screen or alcohol breath test at screening.
  • History of allergic reactions to trastuzumab, benzyl alcohol, murine proteins, or other related drugs.
  • Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.
  • Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
  • History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
  • History of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], and crack) within 1 year prior to screening.
  • Use of trastuzumab or another monoclonal antibody for a medical condition or in the context of another clinical trial.
  • Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to dosing, administration of a biological product in the context of a clinical research study within 90 days prior to dosing, or concomitant participation in an investigational study involving no drug or device administration.
  • Use of medication other than topical products without significant systemic absorption:

    1. prescription medication within 14 days prior to dose administration;
    2. over-the-counter products including natural health products (e.g. food supplements and herbal supplements) within 7 days prior to dosing, with the exception of the occasional use of acetaminophen (up to 2 g daily);
    3. a depot injection or an implant of any drug within 3 months prior to dose administration.
  • Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to dosing.
  • Hemoglobin <128 g/L and hematocrit <0.37 L/L at screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03242239
Other Study ID Numbers  ICMJE ALT02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alteogen, Inc.
Study Sponsor  ICMJE Alteogen, Inc.
Collaborators  ICMJE Cristália Produtos Químicos Farmacêuticos Ltda.
Investigators  ICMJE Not Provided
PRS Account Alteogen, Inc.
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP