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Trial record 1 of 15 for:    ALT-02
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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.

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.

Condition or disease Intervention/treatment Phase
Healthy Biological: ALT02 Biological: EU-licensed Herceptin Biological: US-licensed Herceptin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel, Phase I Pharmacokinetic Trial Comparing The Potential Biosimilar ALT02(Trastuzumab) With Herceptin in Healthy Volunteers
Actual Study Start Date : February 9, 2016
Actual Primary Completion Date : August 4, 2016
Actual Study Completion Date : September 30, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Trastuzumab

Arm Intervention/treatment
Experimental: ALT02 Biological: ALT02
Active Comparator: EU-licensed Herceptin Biological: EU-licensed Herceptin
Active Comparator: US-licensed Herceptin Biological: US-licensed Herceptin



Primary Outcome Measures :
  1. AUC0-inf: area under the concentration-time curve from time zero to infinity [ Time Frame: 43 days ]

Secondary Outcome Measures :
  1. AUC0-t: area under the concentration-time curve from time zero to the last non-zero concentration [ Time Frame: 43 days ]
  2. Cmax: maximum observed concentration [ Time Frame: 43 days ]
  3. Tmax: time of observed Cmax [ Time Frame: 43 days ]
  4. Kel: apparent terminal elimination rate constant [ Time Frame: 43 days ]
  5. T½ el: apparent terminal half-life [ Time Frame: 43 days ]
  6. CL: apparent body clearance, calculated as Dose/AUC0-inf [ Time Frame: 43 days ]
  7. Vd: apparent volume of distribution, calculated as Dose/(kel x AUC0-inf) [ Time Frame: 43 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
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Responsible Party: Alteogen, Inc.
ClinicalTrials.gov Identifier: NCT03242239    
Other Study ID Numbers: ALT02
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017

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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 Alteogen, Inc.:
HER2 Positive Breast Cancer
Trastuzumab
Biosimilar
Additional relevant MeSH terms:
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Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents