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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: DMB-3113; Drug: Adalimumab

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DMB-3113; adalimumab biosimilar	Drug: DMB-3113; subcutaneously injected in a single dose of 40 mg.
ACTIVE_COMPARATOR: adalimumab	Drug: Adalimumab; subcutaneously injected in a single dose of 40 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
AUC from 0 to the last measurable concentration	Day 1 to Day 71
Time to reach the peak concentration (tmax)	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
Elimination rate constant (kel)	Day 1 to Day 71
Elimination half life (t1/2)	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
Incidence of adverse events	Day 1 to Day 71

Collaborators and Investigators

• Sponsor: Meiji Seika Pharma Co., Ltd.
• Investigators: Study Director: Hideki Fushimi, Manager, Meiji Seika Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (ACTUAL): January 17, 2017
• Study Completion (ACTUAL): January 17, 2017

Study Registration Dates

• First Submitted: October 5, 2016
• First Submitted That Met QC Criteria: October 6, 2016
• First Posted (ESTIMATE): October 7, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 17, 2017
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Bioequivalence, Biosimilarity, Pharmacokinetics, adalimumab
• Additional Relevant MeSH Terms: Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: DMB-3113-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO