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

NCT ID: NCT02927353

Last Updated: 2017-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-01-17

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

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DMB-3113

adalimumab biosimilar

Group Type: EXPERIMENTAL

DMB-3113

Intervention Type: DRUG

subcutaneously injected in a single dose of 40 mg.

adalimumab

adalimumab

Group Type: ACTIVE_COMPARATOR

Adalimumab

Intervention Type: DRUG

subcutaneously injected in a single dose of 40 mg.

Interventions

DMB-3113

subcutaneously injected in a single dose of 40 mg.

Intervention Type: DRUG

Adalimumab

subcutaneously injected in a single dose of 40 mg.

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Meiji Seika Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hideki Fushimi, Manager

Role: STUDY_DIRECTOR

Meiji Seika Pharma Co., Ltd.

Locations

Fukuoka, , Japan

Countries

Japan

Other Identifiers

DMB-3113-1

Identifier Type: -

Identifier Source: org_study_id