Bioequivalence Study Evaluating the Pharmacokinetics of DMB-3111 and Trastuzumab in Healthy Japanese Male Adults

Study Overview
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Brief Summary
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This study is a randomized Trastuzumab-controlled double-blind parallel-group study.

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: DMB-3111
* Drug: trastuzumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Japanese male adults Body Mass Index (BMI) between 17.6 and 26.4 kg/m² at the time of screening BMI = Body Weight (kg)/[Height (m)]² The individual who freely consents to participate after receiving a detailed explanation of the clinical study and completely understanding thereof, and who has capacity to follow precautions and provide written consent. Exclusion Criteria: History of hypersensitivity to components of Trastuzumab or diphenhydramine or any other drug Use of any ethical drug within 2 weeks before investigational product administration or any over-the-counter drug within 1 week before investigational product administration that would affect study participation in the opinion of the investigator or subinvestigators (except for diphenhydramine, which will be used concomitantly in the present clinical trial and any drug applied locally and having no systemic actions) History of allergic symptoms such as bronchial asthma and urticaria that would affect study participation in the opinion of the investigator or subinvestigators History of cardiac disorders, hypertension, coronary artery disease (e.g., myocardial infarction, angina), and/or vascular disorder; ongoing palpitations, shortness of breath, and/or tachycardia

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DMB-3111<br>6 mg/kg is once given in intravenous drip infusion taking 90 min | Drug: DMB-3111<br> <br> |
| Active Comparator: trastuzumab<br>6 mg/kg is once given in intravenous drip infusion taking 90 min | Drug: trastuzumab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Concentration-Time (AUC) |  | Day1-71 | 
| Maximum observed serum concentration (Cmax) |  | Day1-71 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve (AUC) from 0 to time of the last measurable concentration |  | Day1-71 | 
| Area under the concentration-time curve (AUC) from 0 to infinity |  | Day1-71 | 
| Time to reach the peak concentration (tmax) |  | Day1-71 | 
| Mean residence time (MRT) from 0 to final sampling time point |  | Day1-71 | 
| Mean residence time (MRT) from 0 to infinity |  | Day1-71 | 
| elimination rate constant (kel) |  | Day1-71 | 
| Elimination half life (t1/2) |  | Day1-71 | 
| Clearance (CL) |  | Day1-71 | 
| Incidence of adverse events |  | Day1-71 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence, Biosimilarity, Similarity, Pharmacokinetics, Phase I, Trastuzumab, Healthy Male Volunteers, Single-dose, HER-2, Oncology