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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03776240




Registration number
NCT03776240
Ethics application status
Date submitted
13/12/2018
Date registered
14/12/2018

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 0 0
TROIKA-1
Universal Trial Number (UTN)
Trial acronym
TROIKA-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HD201
Treatment: Drugs - EU-Herceptin
Treatment: Drugs - US-Herceptin

Experimental: HD201 - Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion

Active comparator: EU-licensed Herceptin - Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion

Active comparator: US-licensed Herceptin - Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion


Treatment: Drugs: HD201
Single-dose 6mg/kg body weight by 90 minute intravenous infusion

Treatment: Drugs: EU-Herceptin
Single-dose 6mg/kg body weight by 90 minute intravenous infusion

Treatment: Drugs: US-Herceptin
Single-dose 6mg/kg body weight by 90 minute intravenous infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under Curve (AUC, Pharmacokinetics)
Timepoint [1] 0 0
Up to day 54
Secondary outcome [1] 0 0
Immunogenicity: Incidence of anti-herceptin antibodies
Timepoint [1] 0 0
0 hour, Day 15, Day 29, Day 43, and Day 54 post-dose

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/08/2019
Sample size
Target
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Q Pharm - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Prestige Biopharma Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Litha Jaison
Address 0 0
Prestige Biopharma Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03776240