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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: DMB-3113; Drug: Adalimumab

• Registration Number: NCT02927353
• Lead Sponsor: Meiji Seika Pharma Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-06
• Study Start: 2016-08
• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2016-10-06
• Study First Posted: 2016-10-07
• Primary Completion: 2017-01-17
• Study Completion: 2017-01-17
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DMB-3113	DMB-3113	adalimumab biosimilar
adalimumab	Adalimumab	adalimumab

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Elimination half life (t1/2)	Day 1 to Day 71
AUC from 0 to the last measurable concentration	Day 1 to Day 71
Mean residence time (MRT) from 0 to final sampling time point	Day 1 to Day 71
MRT from 0 to infinity	Day 1 to Day 71
Observed clearance (CL/F)	Day 1 to Day 71
Observed volume of distribution (V/F)	Day 1 to Day 71
Time to reach the peak concentration (tmax)	Day 1 to Day 71
Elimination rate constant (kel)	Day 1 to Day 71
Incidence of adverse events	Day 1 to Day 71