HealthyPhase 1NCT03242239
A Comparing Study Between ALT02(Trastuzumab Biosimilar) and Herceptin® in Healthy Subjects
A Phase 1 study testing ALT02, EU-licensed Herceptin and US-licensed Herceptin in people with Healthy, run by Alteogen, Inc..
Trial 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. 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
- What is being tested?
- ALT02, EU-licensed Herceptin and US-licensed Herceptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 9 Feb 2016to 30 Sep 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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]).
Show all 15Show fewer
- 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:
- 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 (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 dosing.
- Hemoglobin <128 g/L and hematocrit <0.37 L/L at screening.
About this study
Official title: A Randomized, Double-Blind, Parallel, Phase I Pharmacokinetic Trial Comparing The Potential Biosimilar ALT02(Trastuzumab) With Herceptin in Healthy Volunteers
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.
- Conditions
- Healthy
- Being tested
- ALT02, EU-licensed Herceptin, US-licensed Herceptin
- Keywords
- HER2 Positive Breast Cancer, Trastuzumab, Biosimilar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALT02Biological
EU-licensed HerceptinBiological
US-licensed HerceptinBiological
| Study group | Role | What they receive |
|---|---|---|
| ALT02 | Experimental | Not described Receives: Biological: ALT02 |
| EU-licensed Herceptin | Active comparator | Not described Receives: Biological: EU-licensed Herceptin |
| US-licensed Herceptin | Active comparator | Not described Receives: Biological: US-licensed Herceptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-inf: area under the concentration-time curve from time zero to infinity
Measured: 43 days
Secondary outcomes (7)
AUC0-t: area under the concentration-time curve from time zero to the last non-zero concentration
Measured: 43 days
Cmax: maximum observed concentration
Measured: 43 days
Tmax: time of observed Cmax
Measured: 43 days
Kel: apparent terminal elimination rate constant
Measured: 43 days
T½ el: apparent terminal half-life
Measured: 43 days
CL: apparent body clearance, calculated as Dose/AUC0-inf
Measured: 43 days
Vd: apparent volume of distribution, calculated as Dose/(kel x AUC0-inf)
Measured: 43 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start9 Feb 2016
- Primary completion4 Aug 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alteogen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cristália Produtos Químicos Farmacêuticos Ltda.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242239
- Sponsor's protocol ID
- ALT02
- Status last verified
- Aug 2017
- First submitted
- 2 Aug 2017
- Last updated
- 21 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel, Phase I Pharmacokinetic Trial Comparing The Potential Biosimilar ALT02(Trastuzumab) With Herceptin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03242239
- Acronym / sponsor ID
- ALT02
- Conditions
- Healthy
- Keywords
- HER2 Positive Breast Cancer, Trastuzumab, Biosimilar
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Alteogen, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cristália Produtos Químicos Farmacêuticos Ltda.
- Study start
- 9 Feb 2016 (actual)
- Primary completion
- 4 Aug 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 8 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALT02 | Experimental | Biological: ALT02 |
| EU-licensed Herceptin | Active comparator | Biological: EU-licensed Herceptin |
| US-licensed Herceptin | Active comparator | Biological: US-licensed Herceptin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (15 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 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.
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 |
|---|---|---|
| ALT02 | Biological | ALT02 |
| EU-licensed Herceptin | Biological | EU-licensed Herceptin |
| US-licensed Herceptin | Biological | US-licensed Herceptin |
Primary outcome
AUC0-inf: area under the concentration-time curve from time zero to infinity
Time frame: 43 days
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALT02, EU-licensed Herceptin and US-licensed Herceptin in people with Healthy, run by Alteogen, Inc..
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 2 inclusion and 15 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 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AUC0-inf: area under the concentration-time curve from time zero to infinity (time frame: 43 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2017.