A Phase 1 Pharmacokinetic Bioequivalence Study of DMB-3113 and Adalimumab in Healthy Japanese Adult Male Subjects (DMB-3113-1)

Meiji Seika Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Adalimumab; Drug: DMB-3113

Study type: Interventional

Funder types: Industry

Identifiers

NCT02927353

DMB-3113-1

Details and patient eligibility

About

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

Enrollment: 180 patients

Sex: Male

Ages: 20 to 39 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

DMB-3113

Experimental group

Description:

adalimumab biosimilar

Treatment:

Drug: DMB-3113

adalimumab

Active Comparator group

Description:

adalimumab

Treatment:

Drug: Adalimumab