Healthy Volunteer
Conditions
Keywords
Bioequivalence, Biosimilarity, Pharmacokinetics, adalimumab
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
Interventions
DRUGDMB-3113
subcutaneously injected in a single dose of 40 mg.
DRUGAdalimumab
subcutaneously injected in a single dose of 40 mg.
Sponsors
Meiji Seika Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 39 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the serum concentration-time curve (AUC) from 0 to final sampling time point | Day 1 to Day 71 |
| AUC from 0 to infinity | Day 1 to Day 71 |
| Maximum serum concentration (Cmax) | Day 1 to Day 71 |
Secondary
| Measure | Time frame |
|---|---|
| MRT from 0 to infinity | Day 1 to Day 71 |
| Elimination rate constant (kel) | Day 1 to Day 71 |
| Elimination half life (t1/2) | Day 1 to Day 71 |
| AUC from 0 to the last measurable concentration | Day 1 to Day 71 |
| Observed volume of distribution (V/F) | Day 1 to Day 71 |
| Incidence of adverse events | Day 1 to Day 71 |
| Observed clearance (CL/F) | Day 1 to Day 71 |
| Time to reach the peak concentration (tmax) | Day 1 to Day 71 |
| Mean residence time (MRT) from 0 to final sampling time point | Day 1 to Day 71 |
Countries
Japan
Outcome results
None listed