Healthy VolunteerPhase 1DMB-3113-1NCT02927353
A Phase 1 Pharmacokinetic Bioequivalence Study of DMB-3113 and Adalimumab in Healthy Japanese Adult Male Subjects
A Phase 1 study testing DMB-3113 and Adalimumab in people with Healthy Volunteer, run by Meiji Seika Pharma Co., Ltd. at 1 site in Japan.
Trial summary
To determine the pharmacokinetic bioequivalence of DMB-3113 and adalimumab and to confirm the safety of the study drug in healthy Japanese adult male subjects 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-3113 and Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2016to 17 Jan 2017
- 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;
- The Body Mass Index (BMI) of the subjects must be from 17.6 to 26.4 kg/m2 at the time of the screening test;and
- Subjects must take a screening test within the 4 weeks before the date of administration of the study drug; subjects must take a screening test before the date of administration of the study drug and exhibit no clinically abnormal findings in the judgment of the investigator or any of the subinvestigators
Who cannot join
- Concurrent or history of potentially fatal infections such as opportunistic infections, including sepsis, pneumonia, and fungal infection;
- Individuals with history of tuberculosis or diagnosed with tuberculosis by interview, chest X-ray examination, or interferon-gamma release assay;
- Concurrent or history of demyelinating disease (multiple sclerosis, etc.);
- Concurrent or history of congestive cardiac failure;
- Concurrent or history of allergic symptoms such as asthma bronchial, drug-induced rash, and urticaria, which, in the judgment of the investigator or any of the subinvestigators, may affect participation in this clinical study; or
- Concurrent or history of cardiac, hepatic, renal, gastrointestinal, respiratory, and/or hematological function disorders, which, in the judgment of the investigator or any of the subinvestigators, may affect participation in this clinical study
Trial locations and contacts
1 site in 1 country.
About this study
To determine the pharmacokinetic bioequivalence of DMB-3113 and adalimumab and to confirm the safety of the study drug in healthy Japanese adult male subjects
- Conditions
- Healthy Volunteer
- Being tested
- DMB-3113, Adalimumab
- Keywords
- Bioequivalence, Biosimilarity, Pharmacokinetics, adalimumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMB-3113Drug
subcutaneously injected in a single dose of 40 mg.
AdalimumabDrug
subcutaneously injected in a single dose of 40 mg.
| Study group | Role | What they receive |
|---|---|---|
| DMB-3113 | Experimental | adalimumab biosimilar Receives: Drug: DMB-3113 |
| adalimumab | Active comparator | adalimumab Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum concentration-time curve (AUC) from 0 to final sampling time point
Measured: Day 1 to Day 71
AUC from 0 to infinity
Measured: Day 1 to Day 71
Maximum serum concentration (Cmax)
Measured: Day 1 to Day 71
Secondary outcomes (9)
AUC from 0 to the last measurable concentration
Measured: Day 1 to Day 71
Time to reach the peak concentration (tmax)
Measured: Day 1 to Day 71
Mean residence time (MRT) from 0 to final sampling time point
Measured: Day 1 to Day 71
MRT from 0 to infinity
Measured: Day 1 to Day 71
Elimination rate constant (kel)
Measured: Day 1 to Day 71
Elimination half life (t1/2)
Measured: Day 1 to Day 71
Observed clearance (CL/F)
Measured: Day 1 to Day 71
Observed volume of distribution (V/F)
Measured: Day 1 to Day 71
Incidence of adverse events
Measured: Day 1 to Day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study startAug 2016
- Primary completion17 Jan 2017
- Study completion17 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meiji Seika Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hideki Fushimi, Manager, Study director, Meiji Seika Pharma Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927353
- Sponsor's protocol ID
- DMB-3113-1
- Acronym
- DMB-3113-1
- Status last verified
- Jun 2016
- First submitted
- 5 Oct 2016
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Pharmacokinetic Bioequivalence Study of DMB-3113 and Adalimumab in Healthy Japanese Adult Male Subjects
- ClinicalTrials.gov ID
- NCT02927353
- Acronym / sponsor ID
- DMB-3113-1 / DMB-3113-1
- Conditions
- Healthy Volunteer
- Keywords
- Bioequivalence, Biosimilarity, Pharmacokinetics, adalimumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Meiji Seika Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- 17 Jan 2017 (actual)
- Study completion
- 17 Jan 2017 (actual)
- First posted
- 7 Oct 2016 (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.
To determine the pharmacokinetic bioequivalence of DMB-3113 and adalimumab and to confirm the safety of the study drug in healthy Japanese adult male subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMB-3113 | Experimental | Drug: DMB-3113adalimumab biosimilar |
| adalimumab | Active comparator | Drug: Adalimumabadalimumab |
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;
- The Body Mass Index (BMI) of the subjects must be from 17.6 to 26.4 kg/m2 at the time of the screening test;and
- Subjects must take a screening test within the 4 weeks before the date of administration of the study drug; subjects must take a screening test before the date of administration of the study drug and exhibit no clinically abnormal findings in the judgment of the investigator or any of the subinvestigators
Key exclusion criteria (6 listed)
- Concurrent or history of potentially fatal infections such as opportunistic infections, including sepsis, pneumonia, and fungal infection;
- Individuals with history of tuberculosis or diagnosed with tuberculosis by interview, chest X-ray examination, or interferon-gamma release assay;
- Concurrent or history of demyelinating disease (multiple sclerosis, etc.);
- Concurrent or history of congestive cardiac failure;
- Concurrent or history of allergic symptoms such as asthma bronchial, drug-induced rash, and urticaria, which, in the judgment of the investigator or any of the subinvestigators, may affect participation in this clinical study; or
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-3113subcutaneously injected in a single dose of 40 mg. | Drug | DMB-3113 |
| Adalimumabsubcutaneously injected in a single dose of 40 mg. | Drug | adalimumab |
Primary outcome
Area under the serum concentration-time curve (AUC) from 0 to final sampling time point
Time frame: Day 1 to Day 71
AUC from 0 to infinity
Time frame: Day 1 to Day 71
Maximum serum concentration (Cmax)
Time frame: Day 1 to Day 71
9 secondary outcomes
AUC from 0 to the last measurable concentration
Time frame: Day 1 to Day 71
Time to reach the peak concentration (tmax)
Time frame: Day 1 to Day 71
Mean residence time (MRT) from 0 to final sampling time point
Time frame: Day 1 to Day 71
MRT from 0 to infinity
Time frame: Day 1 to Day 71
Elimination rate constant (kel)
Time frame: Day 1 to Day 71
Elimination half life (t1/2)
Time frame: Day 1 to Day 71
Observed clearance (CL/F)
Time frame: Day 1 to Day 71
Observed volume of distribution (V/F)
Time frame: Day 1 to Day 71
Incidence of adverse events
Time frame: Day 1 to Day 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 22 Aug 2017.
- Individual participant dataSharing planned: No
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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.
Hideki Fushimi, Manager study director
Meiji Seika Pharma Co., Ltd.
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-3113 and Adalimumab 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 6 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 22 Aug 2017. 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 serum concentration-time curve (AUC) from 0 to final sampling time point (time frame: Day 1 to Day 71). 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?
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 22 Aug 2017.