Healthy Volunteer
Conditions
Keywords
Bioequivalence, Biosimilarity, Similarity, Pharmacokinetics, Phase I, Trastuzumab, Healthy Male Volunteers, Single-dose, HER-2, Oncology
Brief summary
This study is a randomized Trastuzumab-controlled double-blind parallel-group study.
Interventions
DRUGDMB-3111
DRUGtrastuzumab
Sponsors
Dong-A Pharmaceutical
Meiji Seika Pharma Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy Japanese male adults 2. Body Mass Index (BMI) between 17.6 and 26.4 kg/m² at the time of screening BMI = Body Weight (kg)/\[Height (m)\]² 3. 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
1. History of hypersensitivity to components of Trastuzumab or diphenhydramine or any other drug 2. 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) 3. History of allergic symptoms such as bronchial asthma and urticaria that would affect study participation in the opinion of the investigator or subinvestigators 4. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed serum concentration (Cmax) | Day1-71 |
| Area Under the Concentration-Time (AUC) | Day1-71 |
Secondary
| Measure | Time frame |
|---|---|
| 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 half life (t1/2) | Day1-71 |
| Clearance (CL) | Day1-71 |
| Incidence of adverse events | Day1-71 |
| elimination rate constant (kel) | Day1-71 |
| Area under the concentration-time curve (AUC) from 0 to time of the last measurable concentration | Day1-71 |
Other
| Measure | Time frame |
|---|---|
| Incidence of anti-trastuzumab antibodies (ADAs) | Day1-71 |
Countries
Japan
Outcome results
None listed