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A Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and EU-Herceptin® and US-Herceptin® in Healthy Male Subjects (TROIKA-1)

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ClinicalTrials.gov Identifier: NCT03776240
Recruitment Status : Completed
First Posted : December 14, 2018
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Prestige Biopharma Pte Ltd

Tracking Information
First Submitted Date  ICMJE December 13, 2018
First Posted Date  ICMJE December 14, 2018
Last Update Posted Date August 30, 2019
Actual Study Start Date  ICMJE April 1, 2019
Actual Primary Completion Date August 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2018)
Area under Curve (AUC, Pharmacokinetics) [ Time Frame: Up to day 54 ]
Sampling will be performed in all patients to compare PK though values of HD201 and Herceptin
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03776240 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2018)
Immunogenicity: Incidence of anti-herceptin antibodies [ Time Frame: 0 hour, Day 15, Day 29, Day 43, and Day 54 post-dose ]
Incidence of anti-herceptin antibodies
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 Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and EU-Herceptin® and US-Herceptin® in Healthy Male Subjects
Official Title  ICMJE A Phase I, Double-Blind, Randomised, Parallel Group Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and EU-Herceptin® and US-Herceptin® in Healthy Male Subjects
Brief Summary The purpose of the study is to demonstrate demonstrate the pharmacokinetic (PK) similarity of HD201 to the European (EU) and American (US) reference products Herceptin, following a single i.v. infusion of 6 mg/kg in healthy volunteers.
Detailed Description This is a double-blind, randomised, parallel group study, where a total of 105 healthy adult male volunteers, ≥ 18 and ≤ 55 years of age, non-smoker, will be dosed; 35 subjects per treatment group, randomly assigned to one of the 3 treatment arms.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Screening
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: HD201
    Single-dose 6mg/kg body weight by 90 minute intravenous infusion
    Other Name: Trastuzumab
  • Drug: EU-Herceptin
    Single-dose 6mg/kg body weight by 90 minute intravenous infusion
    Other Name: Trastuzumab
  • Drug: US-Herceptin
    Single-dose 6mg/kg body weight by 90 minute intravenous infusion
    Other Name: Trastuzumab
Study Arms  ICMJE
  • Experimental: HD201
    Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion
    Intervention: Drug: HD201
  • Active Comparator: EU-licensed Herceptin
    Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion
    Intervention: Drug: EU-Herceptin
  • Active Comparator: US-licensed Herceptin
    Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion
    Intervention: Drug: US-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: December 13, 2018)
105
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 19, 2019
Actual Primary Completion Date August 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male, non-smoker (no use of tobacco products within 3 months prior to screening), ≥ 18 and ≤ 55 years of age, with BMI > 18.5 and < 30.0 kg/m2 and body weight ≥ 50.0 kg.
  2. Healthy as defined by:

    1. the absence of clinically significant illness and surgery within 4 weeks prior to dosing. Inclusion pre-dosing is at the discretion of the Principal Investigator.
    2. the absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
    3. a LVEF within the normal range as measured by echocardiogram (ECHO) within 4 weeks prior to randomization.
    4. the absence of clinically significant history of anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.
  3. Male subjects who are not vasectomized for at least 6 months, and who are sexually active with non-sterile female partner [sterile female partners include post-menopausal women (absence of menses for 12 months prior to drug administration) or women who have had a tubal ligation, hysterectomy, or bilateral oophorectomy (at least 6 months prior to drug administration)] must be willing to use one of the following acceptable contraceptive method throughout the study and for 90 days after the last study drug administration:

    1. simultaneous use of condom, and for the female partner hormonal contraceptives (used since at least 4 weeks) or intra-uterine contraceptive device (placed since at least 4 weeks);
    2. simultaneous use of male condom, and for the female partner, diaphragm with intravaginally applied spermicide.
  4. Male subjects, including men who have had vasectomy, with a pregnant partner must agree to use a condom throughout the study and for 90 days after the last study drug administration.
  5. Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.
  6. Capable of consent.

Exclusion Criteria:

f the following applies will be excluded from the study:

  1. 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.
  2. Positive urine drug screen at screening.
  3. History of allergic reactions to trastuzumab, benzyl alcohol, murine proteins, or other related drugs.
  4. Any reason which, in the opinion of the Principal Investigator, would prevent the subject from participating in the study.
  5. Clinically significant ECG abnormalities (QTc >450 ms) and 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.
  6. 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]).
  7. 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], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening.
  8. Previous use of trastuzumab or another monoclonal antibody for a medical condition or in the context of another clinical trial.
  9. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
  10. 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 (paracetamol - up to 2 g daily);
    3. a depot injection or an implant of any drug within 3 months prior to dose administration.
  11. 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 the first dosing.
  12. Hemoglobin < 12.8 g/dL 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 Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03776240
Other Study ID Numbers  ICMJE TROIKA-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Prestige Biopharma Pte Ltd
Study Sponsor  ICMJE Prestige Biopharma Pte Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Lisa S Park Prestige Biopharma Pte Ltd
PRS Account Prestige Biopharma Pte Ltd
Verification Date August 2019

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