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

Healthy Volunteer Clinical Trial

— DMB-3113-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02927353
• Other study ID #: DMB-3113-1
• Status: Completed
• Phase: Phase 1
• First received: October 5, 2016
• Last updated: August 17, 2017
• Start date: August 2016
• Est. completion date: January 17, 2017

Study information

• Verified date: June 2016
• Source: Meiji Seika Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: January 17, 2017
• Est. primary completion date: January 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• DMB-3113
subcutaneously injected in a single dose of 40 mg.
• Adalimumab
subcutaneously injected in a single dose of 40 mg.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meiji Seika Pharma Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum concentration-time curve (AUC) from 0 to final sampling time point		Day 1 to Day 71
Primary	AUC from 0 to infinity		Day 1 to Day 71
Primary	Maximum serum concentration (Cmax)		Day 1 to Day 71
Secondary	AUC from 0 to the last measurable concentration		Day 1 to Day 71
Secondary	Time to reach the peak concentration (tmax)		Day 1 to Day 71
Secondary	Mean residence time (MRT) from 0 to final sampling time point		Day 1 to Day 71
Secondary	MRT from 0 to infinity		Day 1 to Day 71
Secondary	Elimination rate constant (kel)		Day 1 to Day 71
Secondary	Elimination half life (t1/2)		Day 1 to Day 71
Secondary	Observed clearance (CL/F)		Day 1 to Day 71
Secondary	Observed volume of distribution (V/F)		Day 1 to Day 71
Secondary	Incidence of adverse events		Day 1 to Day 71