Healthy volunteers
Conditions
Interventions
investigational material(s)
Generic name etc : DMB-3113
INN of investigational material :
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigati
Sponsors
Meiji Seika Pharma Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion 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
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 |
|---|---|
| Pharmacokinetics AUCt, AUCinf, Cmax | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics and Safety Pharmacokinetics - AUClast, tmax, MRTt, MRTinf, kel, t1/2, CL/F and V/F Safety - Incidence of adverse events and adverse drug reactions related to DMB-3113 or adalimumab | — |
Outcome results
None listed