Clinical trial NCT02927353: A Phase 1 Pharmacokinetic Bioequivalence Study of DMB-3113 and Adalimumab in Healthy Japanese Adult Male Subjects
Official title: A Phase 1 Pharmacokinetic Bioequivalence Study of DMB-3113 and Adalimumab in Healthy Japanese Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Bioequivalence, Biosimilarity, Pharmacokinetics, adalimumab
Lead sponsor: Meiji Seika Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-10-07
Enrollment: 180
Sex: MALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

1. Healthy Japanese male adults;
2. 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
3. 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

Exclusion Criteria:

1. Concurrent or history of potentially fatal infections such as opportunistic infections, including sepsis, pneumonia, and fungal infection;
2. Individuals with history of tuberculosis or diagnosed with tuberculosis by interview, chest X-ray examination, or interferon-gamma release assay;
3. Concurrent or history of demyelinating disease (multiple sclerosis, etc.);
4. Concurrent or history of congestive cardiac failure;
5. 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
6. 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

Primary outcomes:
measure: Area under the serum concentration-time curve (AUC) from 0 to final sampling time point
timeFrame: Day 1 to Day 71
measure: AUC from 0 to infinity
timeFrame: Day 1 to Day 71
measure: Maximum serum concentration (Cmax)
timeFrame: Day 1 to Day 71
Secondary outcomes:
measure: AUC from 0 to the last measurable concentration
timeFrame: Day 1 to Day 71
measure: Time to reach the peak concentration (tmax)
timeFrame: Day 1 to Day 71
measure: Mean residence time (MRT) from 0 to final sampling time point
timeFrame: Day 1 to Day 71
measure: MRT from 0 to infinity
timeFrame: Day 1 to Day 71
measure: Elimination rate constant (kel)
timeFrame: Day 1 to Day 71
measure: Elimination half life (t1/2)
timeFrame: Day 1 to Day 71
measure: Observed clearance (CL/F)
timeFrame: Day 1 to Day 71
measure: Observed volume of distribution (V/F)
timeFrame: Day 1 to Day 71
measure: Incidence of adverse events
timeFrame: Day 1 to Day 71
Other outcomes:
Locations:
city: Fukuoka
country: Japan
Study officials:
affiliation: Meiji Seika Pharma Co., Ltd.
name: Hideki Fushimi, Manager
role: STUDY_DIRECTOR
References: