Healthy VolunteersPhase 1TROIKA-1NCT03776240

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

A Phase 1 study testing HD201, EU-Herceptin and US-Herceptin in people with Healthy Volunteers, run by Prestige Biopharma Limited at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: HD201, EU-Herceptin and US-Herceptin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 105 participants
Where: 1 siteAustralia
Study dates: 1 Apr 2019to 19 Aug 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.
Healthy as defined by:
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.
the absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
a LVEF within the normal range as measured by echocardiogram (ECHO) within 4 weeks prior to randomization.
the absence of clinically significant history of anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

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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:
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);
simultaneous use of male condom, and for the female partner, diaphragm with intravaginally applied spermicide.
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.
Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.
Capable of consent.

Who cannot join

f the following applies will be excluded from the study:
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 at screening.
History of allergic reactions to trastuzumab, benzyl alcohol, murine proteins, or other related drugs.
Any reason which, in the opinion of the Principal Investigator, would prevent the subject from participating in the study.
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.

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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], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening.
Previous 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 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.
Use of medication other than topical products without significant systemic absorption:
prescription medication within 14 days prior to dose administration;
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);
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 the first dosing.
Hemoglobin < 12.8 g/dL and hematocrit < 0.37 L/L at screening.

Trial locations and contacts

1 site in 1 country.

Australia1 site

Q Pharm
Brisbane

Other trials in Australia

About this study

Official 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

Read the 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.

Conditions: Healthy Volunteers
Being tested: HD201, EU-Herceptin, US-Herceptin
Keywords: randomized, double-blind

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HD201Drug
Also called Trastuzumab
Single-dose 6mg/kg body weight by 90 minute intravenous infusion
EU-HerceptinDrug
Also called Trastuzumab
Single-dose 6mg/kg body weight by 90 minute intravenous infusion
US-HerceptinDrug
Also called Trastuzumab
Single-dose 6mg/kg body weight by 90 minute intravenous infusion

Study groups in NCT03776240
Study group	Role	What they receive
HD201	Experimental	Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion Receives: Drug: HD201
EU-licensed Herceptin	Active comparator	Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion Receives: Drug: EU-Herceptin
US-licensed Herceptin	Active comparator	Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion Receives: Drug: US-Herceptin

What is being measured

The primary outcome is the main question the study is designed to answer.

Trastuzumab Serum PK Parameter (AUC0-inf)
Sampling will be performed in all patients to compare PK though values of HD201 and Herceptin. Samples were collected from 0-1272 hours on Days 1-54.
Measured: Up to day 54
Trastuzumab Serum PK Parameter (AUC0-last)
Sampling will be performed in all patients to compare PK though values of HD201 and Herceptin
Measured: Up to Day 54
Trastuzumab Serum PK Parameter (Cmax)
Sampling will be performed in all patients to compare PK though values of HD201 and Herceptin
Measured: Up to Day 54

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201919 Aug 2019

First posted14 Dec 2018
Study start1 Apr 2019
Primary completion19 Aug 2019
Study completion19 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03776240
Sponsor's protocol ID: TROIKA-1
Acronym: TROIKA-1
Status last verified: Feb 2023
First submitted: 13 Dec 2018
Last updated: 7 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Demarchi M, Coliat P, Mclendon K, Chung Shii Hii J, Feyaerts P, Ang F, Jaison L, Deforce F, Derde MP, Kim MJ, Park LS, Detappe A, Pivot X. TROIKA-1: A double-blind, randomized, parallel group, study aimed to demonstrate the equivalent pharmacokinetic profile of HD201, a potential biosimilar candidate to trastuzumab, versus EU-Herceptin(R) and US-Herceptin(R) in healthy male subjects. Pharmacol Res Perspect. 2021 Aug;9(4):e00839. doi: 10.1002/prp2.839.
PubMed 34309241

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT03776240
Acronym / sponsor ID: TROIKA-1 / TROIKA-1
Conditions: Healthy Volunteers
Keywords: randomized, double-blind
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: Prestige Biopharma LimitedIndustry (pharma, biotech, devices)
Study start: 1 Apr 2019 (actual)
Primary completion: 19 Aug 2019 (actual)
Study completion: 19 Aug 2019 (actual)
First posted: 14 Dec 2018 (actual)
Results: Posted 7 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
HD201	Experimental	Drug: HD201Trastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion
EU-licensed Herceptin	Active comparator	Drug: EU-HerceptinTrastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion
US-licensed Herceptin	Active comparator	Drug: US-HerceptinTrastuzumab Single-dose 6mg/kg body weight by 90 minute intravenous infusion

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

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.
Healthy as defined by:
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:
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.
Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.

Key exclusion criteria (16 listed)

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 at screening.
History of allergic reactions to trastuzumab, benzyl alcohol, murine proteins, or other related drugs.
Any reason which, in the opinion of the Principal Investigator, would prevent the subject from participating in the study.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HD201Also: TrastuzumabSingle-dose 6mg/kg body weight by 90 minute intravenous infusion	Drug	HD201
EU-HerceptinAlso: TrastuzumabSingle-dose 6mg/kg body weight by 90 minute intravenous infusion	Drug	EU-licensed Herceptin
US-HerceptinAlso: TrastuzumabSingle-dose 6mg/kg body weight by 90 minute intravenous infusion	Drug	US-licensed Herceptin

Primary outcome

Trastuzumab Serum PK Parameter (AUC0-inf)
Time frame: Up to day 54
Sampling will be performed in all patients to compare PK though values of HD201 and Herceptin. Samples were collected from 0-1272 hours on Days 1-54.
Trastuzumab Serum PK Parameter (AUC0-last)
Time frame: Up to Day 54
Sampling will be performed in all patients to compare PK though values of HD201 and Herceptin
Trastuzumab Serum PK Parameter (Cmax)
Time frame: Up to Day 54
Sampling will be performed in all patients to compare PK though values of HD201 and Herceptin

Results and safety

Results posted to the registry on 7 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HD201	35	33
EU-licensed Herceptin	35	33
US-licensed Herceptin	35	32

Primary outcome: Trastuzumab Serum PK Parameter (AUC0-inf)

Time frame: Up to day 54. Geometric mean (Geometric Coefficient of Variation). Unit: h*μg/mL

Measure	HD201 n = 32	EU-licensed Herceptin n = 34	US-licensed Herceptin n = 31
Value	38350.2 (16.0)	37432.7 (16.7)	37298.5 (15.5)

HD201 vs EU-licensed Herceptin: Geometric Mean Ratio: 102.45 (90% CI 95.95 to 109.40)
EU-licensed Herceptin vs US-licensed Herceptin: Geometric Mean Ratio: 100.36 (90% CI 93.94 to 107.22)
HD201 vs US-licensed Herceptin: Geometric Mean Ratio: 102.82 (90% CI 96.15 to 109.96)

Population analysed: The Pharmacokinetic Parameter (PKP) Population includes all subjects of the PKC Population who received a complete dose of study drug within the maximum prescribed time (i.e. 3 hours ± 10 minutes) and for whom the PK profile can be adequately characterized. Four subjects of the PKC Population were excluded from the PKP population as it was judged by the PK Analyst that the PK profile could not be adequately characterized because 2 or more consecutive samples were missed at the end.

Primary outcome: Trastuzumab Serum PK Parameter (AUC0-last)

Time frame: Up to Day 54. Geometric mean (Geometric Coefficient of Variation). Unit: h*μg/mL

Measure	HD201 n = 32	EU-licensed Herceptin n = 34	US-licensed Herceptin n = 31
Value	36587.5 (17.6)	35337.1 (17.0)	35619.9 (15.3)

HD201 vs EU-licensed Herceptin: Geometric Mean Ratio: 103.54 (90% CI 96.76 to 110.80)
EU-licensed Herceptin vs US-licensed Herceptin: Geometric Mean Ratio: 99.21 (90% CI 92.65 to 106.22)
HD201 vs US-licensed Herceptin: Geometric Mean Ratio: 102.72 (90% CI 95.84 to 110.09)

Primary outcome: Trastuzumab Serum PK Parameter (Cmax)

Time frame: Up to Day 54. Geometric mean (Geometric Coefficient of Variation). Unit: μg/mL

Measure	HD201 n = 32	EU-licensed Herceptin n = 34	US-licensed Herceptin n = 31
Value	148.86 (19.5)	142.28 (15.5)	151.10 (16.6)

HD201 vs EU-licensed Herceptin: Geometric Mean Ratio: 104.62 (90% CI 97.55 to 112.20)
HD201 vs EU-licensed Herceptin: Geometric Mean Ratio: 94.17 (90% CI 87.75 to 101.05)
HD201 vs EU-licensed Herceptin: Geometric Mean Ratio: 98.52 (90% CI 91.71 to 105.82)

Adverse events

Time frame: All (S)AEs were to be collected from the signing of the informed consent form (ICF) until the Day 54. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HD201	0 of 35 (0%)	18 of 35 (51.4%)	0 of 35
EU-licensed Herceptin	1 of 35 (2.9%)	23 of 35 (65.7%)	0 of 35
US-licensed Herceptin	0 of 35 (0%)	24 of 35 (68.6%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34309241Demarchi M, Coliat P, Mclendon K, Chung Shii Hii J, Feyaerts P, Ang F, Jaison L, Deforce F, Derde MP, Kim MJ, Park LS, Detappe A, Pivot X. TROIKA-1: A double-blind, randomized, parallel group, study aimed to demonstrate the equivalent pharmacokinetic profile of HD201, a potential biosimilar candidate to trastuzumab, versus EU-Herceptin(R) and US-Herceptin(R) in healthy male subjects. Pharmacol Res Perspect. 2021 Aug;9(4):e00839. doi: 10.1002/prp2.839.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HD201, EU-Herceptin and US-Herceptin in people with Healthy Volunteers, run by Prestige Biopharma Limited at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trastuzumab Serum PK Parameter (AUC0-inf) (time frame: Up to day 54). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03776240, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.