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

Study Overview
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Brief Summary
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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

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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: DMB-3113
* Drug: Adalimumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DMB-3113<br>adalimumab biosimilar | Drug: DMB-3113<br>* subcutaneously injected in a single dose of 40 mg.<br>|
| Active Comparator: adalimumab<br>adalimumab | Drug: Adalimumab<br>* subcutaneously injected in a single dose of 40 mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Biosimilarity, Pharmacokinetics, adalimumab