HealthyPhase 1NCT03180242
A Pharmacokinetic Study Comparing EG12014 and Herceptin (Trastuzumab) in Healthy Male Volunteers
A Phase 1 study testing EG12014, EU-sourced Herceptin and US-sourced Herceptin in people with Healthy, run by EirGenix, Inc..
Trial summary
The primary objective of this trial is to assess the pharmacokinetic similarity of EG12014 (Test IMP) compared to reference products sourced from the European Union (Reference IMP 1: Herceptin® 150 mg powder for concentrate for solution for infusion) and the United States (Reference IMP 2: Herceptin® 440 mg powder for… 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?
- EG12014, EU-sourced Herceptin and US-sourced Herceptin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 22 Mar 2016to 22 Aug 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
- male Caucasian subject
- age between 18 and 55 years (inclusive)
- physically and mentally healthy as judged by means of medical and standard laboratory examinations
- non-smokers or ex-smokers (stopped at least 6 months ago) with a smoking history of ≤5 pack-year equivalents (1 pack-year equivalent is equal to smoking 1 pack per day for 1 year ) and non-users of other nicotine containing products, confirmed by urine cotinine test
- BMI within the range (including the borders) of 18.5 to 30.0 kg/m2 and body weight not more than 105.0 kg
- Informed consent given in written form according to Section 5.4 of the protocol.
Who cannot join
- participation in another clinical trial at same time or within the preceding 3 months from the screening examination (calculated from the date of the final examination of the previous study)
- randomization into the present trial more than once
- blood donation or blood loss including plasmapheresis of >500 ml in the last 3 months before day 0 of the study
- history of drug abuse or use of illegal drugs: use of soft drugs, e.g. marihuana within 6 months of screening or hard drugs, e.g. cocaine, amphetamines, opioids, phencyclidine within 1 year of screening
- alcohol abuse, i.e. regular use of more than 2 units of alcohol per day or 10 units per week or a history of alcoholism (one unit of alcohol equals 250 ml beer, 125 ml wine or 25 ml spirits) or recovered alcoholics
- regular consumption of beverages or food containing methylxanthines (e.g. coffee, tea, cola, caffeine containing sodas, chocolate) equivalent to more than 500 mg methylxanthines per day
Show all 29Show fewer
- positive drug screening and/or positive alcohol test at entry screening or on hospitalization day 0
- history of allergic diathesis or any clinically significant allergic disease (e.g. asthma or bronchial hyperreactivity, or allergic reactions to insect bites)
- any history of drug hypersensitivity (especially to the active and inactive ingredients of the trastuzumab preparation, or other monoclonal antibody or protein drugs) or intolerance to any sugar (e.g. fructose, glucose, or lactose)
- presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, hematological, gastrointestinal, neurological, psychiatric or other diseases
- clinically significant illness within 4 weeks before day 0 of the study and during the study
- major surgery of the gastrointestinal tract except for appendectomy
- any chronic disease which might interfere with resorption, distribution, metabolism or excretion of the drug
- positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies
- administration of depot injectable solutions or medications with a half-life > 1 week (including study medications) within 6 months from day 0 of the study
- intake of enzyme-inducing, organotoxic or long half-life drugs, including prescription or OTC medications or herbal remedies (such as St. John's wort), within 4 weeks from day 0 of the study
- intake or administration of any systemic or topical medication within 2 weeks of day 0 of the study and during the study, except of up to a total dose of 1000 mg paracetamol or metamizole per day given in case of an adverse event (e.g. IRR's: pyrexia, headache) during the study
- intake of drugs known to alter the major organs or systems such as barbiturates, phenothiazines, cimetidine, omeprazole etc. within the last 2 months
- previous exposure to a monoclonal antibody drug or current or expected use of other biological products.
- systolic blood pressure outside the range of 100 to 140 mmHg and/or diastolic blood pressure outside the range of 60 to 90 mmHg at screening and on day 0
- heart rate outside the range of 50 to 90 beats/min at screening and on day 0
- axillary body temperature outside the interval of 35.5 to 37.1°C at screening and on day 0
- any clinically significant abnormality of the resting ECG (12-lead) (i.e. AV block, 2° to 3°, sinus bradycardia, sick sinus syndrome, SA block)
- laboratory values outside normal range with clinical relevance at screening examination and on day 0 of the study
- special diet due to any reason, e.g. vegetarians
- not fulfilling study specific restrictions given in Sections 9.4 Restrictions and 9.6 Diet of the protocol
- any planned surgery within 78 days after dosing on day 1
- subjects who are known or suspected: not to comply with the study directives or meet the required visit schedules; not to be reliable or trustworthy; not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed; to be in such a precarious financial situation that they no longer weigh up the possible risks of their participation and the unpleasantness they may be involved in.
- left ventricular ejection fraction (LVEF) <55%, assessed by means of transthoracic echocardiography .
About this study
Official title: Phase 1, Double-Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Two-Stage, Comparative Pharmacokinetic Study of EirGenix' Trastuzumab and Herceptin® (Trastuzumab) Sourced From US and EU Administered to Healthy Male Volunteers
The primary objective of this trial is to assess the pharmacokinetic similarity of EG12014 (Test IMP) compared to reference products sourced from the European Union (Reference IMP 1: Herceptin® 150 mg powder for concentrate for solution for infusion) and the United States (Reference IMP 2: Herceptin® 440 mg powder for concentrate for solution for infusion) after intravenous infusion over 90 minutes of a single dose of 6 mg/kg trastuzumab in 3 parallel groups of healthy male subjects.
- Conditions
- Healthy
- Being tested
- EG12014, EU-sourced Herceptin, US-sourced Herceptin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EG12014Biological
EG12014, single-dose IV infusion over 90 min at 6 mg/kg
EU-sourced HerceptinBiological
EU-sourced Herceptin, single-dose IV infusion over 90 min at 6 mg/kg
US-sourced HerceptinBiological
US-sourced Herceptin, single-dose IV infusion over 90 min at 6 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| EG12014 | Experimental | EG12014 Receives: Biological: EG12014 |
| EU-sourced Herceptin | Active comparator | EU-sourced Herceptin Receives: Biological: EU-sourced Herceptin |
| US-sourced Herceptin | Active comparator | US-sourced Herceptin Receives: Biological: US-sourced Herceptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration/time curve, from time 0 h extrapolated to infinity (AUC(0-∞))
Measured: 70 days
Secondary outcomes (10)
Peak Plasma Concentration (Cmax)
Measured: 70 days
Area under the concentration/time curve, calculated by the trapezoidal rule from time 0 h to last observed concentration at time t (AUC(0-t))
Measured: 70 days
Residual area in percent (AUCres)
Measured: 70 days
Serum concentration half-life (t½)
Measured: 70 days
Adverse events
Measured: 70 days
Clinical laboratory values
Measured: 70 days
Local tolerability at infusion site
Measured: 70 days
Vital signs and physical examination results
Measured: 70 days
Electrocardiogram (ECG) measurements
Measured: 70 days
Incidence of anti-drug antibodies (ADA)
Measured: 70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start22 Mar 2016
- Primary completion22 Aug 2016
- Study completion22 Aug 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- EirGenix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180242
- Sponsor's protocol ID
- EGC001
- Status last verified
- Jun 2017
- First submitted
- 17 May 2017
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Double-Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Two-Stage, Comparative Pharmacokinetic Study of EirGenix' Trastuzumab and Herceptin® (Trastuzumab) Sourced From US and EU Administered to Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03180242
- Acronym / sponsor ID
- EGC001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- EirGenix, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Mar 2016 (actual)
- Primary completion
- 22 Aug 2016 (actual)
- Study completion
- 22 Aug 2016 (actual)
- First posted
- 8 Jun 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 primary objective of this trial is to assess the pharmacokinetic similarity of EG12014 (Test IMP) compared to reference products sourced from the European Union (Reference IMP 1: Herceptin® 150 mg powder for concentrate for solution for infusion) and the United States (Reference IMP 2: Herceptin® 440 mg powder for concentrate for solution for infusion) after intravenous infusion over 90 minutes of a single dose of 6 mg/kg trastuzumab in 3 parallel groups of healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EG12014 | Experimental | Biological: EG12014EG12014 |
| EU-sourced Herceptin | Active comparator | Biological: EU-sourced HerceptinEU-sourced Herceptin |
| US-sourced Herceptin | Active comparator | Biological: US-sourced HerceptinUS-sourced Herceptin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- male Caucasian subject
- age between 18 and 55 years (inclusive)
- physically and mentally healthy as judged by means of medical and standard laboratory examinations
- non-smokers or ex-smokers (stopped at least 6 months ago) with a smoking history of ≤5 pack-year equivalents (1 pack-year equivalent is equal to smoking 1 pack per day for 1 year ) and non-users of other nicotine containing products, confirmed by urine cotinine test
- BMI within the range (including the borders) of 18.5 to 30.0 kg/m2 and body weight not more than 105.0 kg
Key exclusion criteria (29 listed)
- participation in another clinical trial at same time or within the preceding 3 months from the screening examination (calculated from the date of the final examination of the previous study)
- randomization into the present trial more than once
- blood donation or blood loss including plasmapheresis of >500 ml in the last 3 months before day 0 of the study
- history of drug abuse or use of illegal drugs: use of soft drugs, e.g. marihuana within 6 months of screening or hard drugs, e.g. cocaine, amphetamines, opioids, phencyclidine within 1 year of screening
- alcohol abuse, i.e. regular use of more than 2 units of alcohol per day or 10 units per week or a history of alcoholism (one unit of alcohol equals 250 ml beer, 125 ml wine or 25 ml spirits) or recovered alcoholics
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 |
|---|---|---|
| EG12014EG12014, single-dose IV infusion over 90 min at 6 mg/kg | Biological | EG12014 |
| EU-sourced HerceptinEU-sourced Herceptin, single-dose IV infusion over 90 min at 6 mg/kg | Biological | EU-sourced Herceptin |
| US-sourced HerceptinUS-sourced Herceptin, single-dose IV infusion over 90 min at 6 mg/kg | Biological | US-sourced Herceptin |
Primary outcome
Area under the concentration/time curve, from time 0 h extrapolated to infinity (AUC(0-∞))
Time frame: 70 days
10 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: 70 days
Area under the concentration/time curve, calculated by the trapezoidal rule from time 0 h to last observed concentration at time t (AUC(0-t))
Time frame: 70 days
Residual area in percent (AUCres)
Time frame: 70 days
Serum concentration half-life (t½)
Time frame: 70 days
Adverse events
Time frame: 70 days
Clinical laboratory values
Time frame: 70 days
Local tolerability at infusion site
Time frame: 70 days
Vital signs and physical examination results
Time frame: 70 days
Electrocardiogram (ECG) measurements
Time frame: 70 days
Incidence of anti-drug antibodies (ADA)
Time frame: 70 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 8 Jun 2017.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 EG12014, EU-sourced Herceptin and US-sourced Herceptin in people with Healthy, run by EirGenix, 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 6 inclusion and 29 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 8 Jun 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?
Area under the concentration/time curve, from time 0 h extrapolated to infinity (AUC(0-∞)) (time frame: 70 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 8 Jun 2017.