Healthy VolunteerPhase 1NCT02100917
Bioequivalence Study Evaluating the Pharmacokinetics of DMB-3111 and Trastuzumab in Healthy Japanese Male Adults
A Phase 1 study testing DMB-3111 and trastuzumab in people with Healthy Volunteer, run by Meiji Seika Pharma Co., Ltd. at 1 site in Japan.
Trial summary
This study is a randomized Trastuzumab-controlled double-blind parallel-group study. Read more about this study
- Who is it for?
- Ages 20 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- DMB-3111 and trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2014to Dec 2014
- 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 20 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Japanese male adults
- Body Mass Index (BMI) between 17.6 and 26.4 kg/m² at the time of screening BMI = Body Weight (kg)/[Height (m)]²
- The individual who freely consents to participate after receiving a detailed explanation of the clinical study and completely understanding thereof, and who has capacity to follow precautions and provide written consent.
Who cannot join
- History of hypersensitivity to components of Trastuzumab or diphenhydramine or any other drug
- Use of any ethical drug within 2 weeks before investigational product administration or any over-the-counter drug within 1 week before investigational product administration that would affect study participation in the opinion of the investigator or subinvestigators (except for diphenhydramine, which will be used concomitantly in the present clinical trial and any drug applied locally and having no systemic actions)
- History of allergic symptoms such as bronchial asthma and urticaria that would affect study participation in the opinion of the investigator or subinvestigators
- History of cardiac disorders, hypertension, coronary artery disease (e.g., myocardial infarction, angina), and/or vascular disorder; ongoing palpitations, shortness of breath, and/or tachycardia
Trial locations and contacts
1 site in 1 country.
About this study
This study is a randomized Trastuzumab-controlled double-blind parallel-group study.
- Conditions
- Healthy Volunteer
- Being tested
- DMB-3111, trastuzumab
- Keywords
- Bioequivalence, Biosimilarity, Similarity, Pharmacokinetics, Phase I, Trastuzumab, Healthy Male Volunteers, Single-dose, HER-2, Oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMB-3111Drug
trastuzumabDrug
| Study group | Role | What they receive |
|---|---|---|
| DMB-3111 | Experimental | 6 mg/kg is once given in intravenous drip infusion taking 90 min Receives: Drug: DMB-3111 |
| trastuzumab | Active comparator | 6 mg/kg is once given in intravenous drip infusion taking 90 min Receives: Drug: trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-Time (AUC)
Measured: Day1-71
Maximum observed serum concentration (Cmax)
Measured: Day1-71
Secondary outcomes (9)
Area under the concentration-time curve (AUC) from 0 to time of the last measurable concentration
Measured: Day1-71
Area under the concentration-time curve (AUC) from 0 to infinity
Measured: Day1-71
Time to reach the peak concentration (tmax)
Measured: Day1-71
Mean residence time (MRT) from 0 to final sampling time point
Measured: Day1-71
Mean residence time (MRT) from 0 to infinity
Measured: Day1-71
elimination rate constant (kel)
Measured: Day1-71
Elimination half life (t1/2)
Measured: Day1-71
Clearance (CL)
Measured: Day1-71
Incidence of adverse events
Measured: Day1-71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meiji Seika Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dong-A Pharmaceutical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100917
- Sponsor's protocol ID
- DMB-3111-2
- Other IDs
- JapicCTI-142486
- Status last verified
- Feb 2015
- First submitted
- 27 Mar 2014
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Morita J, Tanaka M, Nomoto M, Matsuki S, Tsuru T, Matsuguma K, Shiramoto M. Pharmacokinetic Bioequivalence, Safety, and Immunogenicity of DMB-3111, a Trastuzumab Biosimilar, and Trastuzumab in Healthy Japanese Adult Males: Results of a Randomized Trial. BioDrugs. 2016 Feb;30(1):17-25. doi: 10.1007/s40259-015-0153-2.
PubMed 26691837
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study Evaluating the Pharmacokinetics of DMB-3111 and Trastuzumab in Healthy Japanese Male Adults
- ClinicalTrials.gov ID
- NCT02100917
- Acronym / sponsor ID
- DMB-3111-2
- Conditions
- Healthy Volunteer
- Keywords
- Bioequivalence, Biosimilarity, Similarity, Pharmacokinetics, Phase I, Trastuzumab, Healthy Male Volunteers, Single-dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Meiji Seika Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Dong-A Pharmaceutical
- Study start
- Jan 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Apr 2014 (estimated)
- 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.
This study is a randomized Trastuzumab-controlled double-blind parallel-group study.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMB-3111 | Experimental | Drug: DMB-31116 mg/kg is once given in intravenous drip infusion taking 90 min |
| trastuzumab | Active comparator | Drug: trastuzumab6 mg/kg is once given in intravenous drip infusion taking 90 min |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Japanese male adults
- Body Mass Index (BMI) between 17.6 and 26.4 kg/m² at the time of screening BMI = Body Weight (kg)/[Height (m)]²
- The individual who freely consents to participate after receiving a detailed explanation of the clinical study and completely understanding thereof, and who has capacity to follow precautions and provide written consent.
Key exclusion criteria (4 listed)
- History of hypersensitivity to components of Trastuzumab or diphenhydramine or any other drug
- Use of any ethical drug within 2 weeks before investigational product administration or any over-the-counter drug within 1 week before investigational product administration that would affect study participation in the opinion of the investigator or subinvestigators (except for diphenhydramine, which will be used concomitantly in the present clinical trial and any drug applied locally and having no systemic actions)
- History of allergic symptoms such as bronchial asthma and urticaria that would affect study participation in the opinion of the investigator or subinvestigators
- History of cardiac disorders, hypertension, coronary artery disease (e.g., myocardial infarction, angina), and/or vascular disorder; ongoing palpitations, shortness of breath, and/or tachycardia
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 |
|---|---|---|
| DMB-3111 | Drug | DMB-3111 |
| trastuzumab | Drug | trastuzumab |
Primary outcome
Area Under the Concentration-Time (AUC)
Time frame: Day1-71
Maximum observed serum concentration (Cmax)
Time frame: Day1-71
9 secondary outcomes
Area under the concentration-time curve (AUC) from 0 to time of the last measurable concentration
Time frame: Day1-71
Area under the concentration-time curve (AUC) from 0 to infinity
Time frame: Day1-71
Time to reach the peak concentration (tmax)
Time frame: Day1-71
Mean residence time (MRT) from 0 to final sampling time point
Time frame: Day1-71
Mean residence time (MRT) from 0 to infinity
Time frame: Day1-71
elimination rate constant (kel)
Time frame: Day1-71
Elimination half life (t1/2)
Time frame: Day1-71
Clearance (CL)
Time frame: Day1-71
Incidence of adverse events
Time frame: Day1-71
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 10 Feb 2015.
- Derived from this study: PubMed 26691837Morita J, Tanaka M, Nomoto M, Matsuki S, Tsuru T, Matsuguma K, Shiramoto M. Pharmacokinetic Bioequivalence, Safety, and Immunogenicity of DMB-3111, a Trastuzumab Biosimilar, and Trastuzumab in Healthy Japanese Adult Males: Results of a Randomized Trial. BioDrugs. 2016 Feb;30(1):17-25. doi: 10.1007/s40259-015-0153-2.
Related trials for Healthy Volunteer
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
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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 DMB-3111 and trastuzumab in people with Healthy Volunteer, run by Meiji Seika Pharma Co., Ltd. at 1 site in Japan.
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 3 inclusion and 4 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 10 Feb 2015. 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 Japan. 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?
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 (AUC) (time frame: Day1-71). The study lists 2 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 NCT02100917, 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 10 Feb 2015.