A phase 1 pharmacokinetic bioequivalence study of DMB-3113 and adalimumab in healthy Japanese adult male subjects

Meiji Seika Pharma Co., Ltd.0 个研究点目标入组 180 人开始时间: 2016年9月28日最近更新: 2023年10月17日

试验速览

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•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.

•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

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