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

NCT02927353 | Completed Phase 1

• 1 other identifier: DMB-3113-1
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Keywords

Bioequivalence, Biosimilarity, Pharmacokinetics, adalimumab

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• 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

Study Arms (2)

DMB-3113

EXPERIMENTAL

adalimumab biosimilar

Drug: DMB-3113

adalimumab

ACTIVE COMPARATOR

adalimumab

Drug: Adalimumab

Interventions

DMB-3113 DRUG

subcutaneously injected in a single dose of 40 mg.

DMB-3113

Adalimumab DRUG

subcutaneously injected in a single dose of 40 mg.

adalimumab

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Japanese male adults;
• 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
• 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

You may not qualify if:

• Concurrent or history of potentially fatal infections such as opportunistic infections, including sepsis, pneumonia, and fungal infection;
• Individuals with history of tuberculosis or diagnosed with tuberculosis by interview, chest X-ray examination, or interferon-gamma release assay;
• Concurrent or history of demyelinating disease (multiple sclerosis, etc.);
• Concurrent or history of congestive cardiac failure;
• 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
• 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

Sponsors & Collaborators

• Meiji Seika Pharma Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Fukuoka, Japan

Location

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Hideki Fushimi, Manager

  Meiji Seika Pharma Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: October 7, 2016
• Study Start: August 1, 2016
• Primary Completion: January 17, 2017
• Study Completion: January 17, 2017
• Last Updated: August 22, 2017

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)