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

NCT02100917 — Phase 1, Completed, 70 participants, Meiji Seika Pharma Co., Ltd.

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Registry	NCT02100917
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: double
Enrollment	70 (Actual)
Sponsor	Meiji Seika Pharma Co., Ltd. (Industry); collaborators: Dong-A Pharmaceutical
Conditions	Healthy Volunteer
Interventions	DMB-3111, trastuzumab (Drug)
Dates	start 2014-01-01, primary completion 2014-05-01, completion 2014-12-01, first posted 2014-04-01, last updated 2015-02-10
Locations	1 site in Japan

-Summary

This study is a randomized Trastuzumab-controlled double-blind parallel-group study.

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+Arms and interventions

Arm	Type	Interventions	Description
DMB-3111	Experimental	Drug: DMB-3111	6 mg/kg is once given in intravenous drip infusion taking 90 min
trastuzumab	Active comparator	Drug: trastuzumab	6 mg/kg is once given in intravenous drip infusion taking 90 min

DMB-3111 (Drug)
trastuzumab (Drug)

+Outcome measures

Primary outcomes

Area Under the Concentration-Time (AUC) [Day1-71]
Maximum observed serum concentration (Cmax) [Day1-71]

Secondary outcomes

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]

Other outcomes

Incidence of anti-trastuzumab antibodies (ADAs) [Day1-71]

+Eligibility

Sex: Male, ages: 20 Years to 39 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
	Fukuoka, Fukuoka	Japan

+Publications

Results publication: Morita J, Tanaka M, Nomoto M, Matsuki S, Tsuru T, Matsuguma K, Shiramoto M. Pharmacokinetic Bioequivalence, Safety, and Immunogenicity of DMB-3111, a Trastuzumab Biosimilar, and Trastuzumab in Healthy Japanese Adult Males: Results of a Randomized Trial. BioDrugs. 2016 Feb;30(1):17-25. doi: 10.1007/s40259-015-0153-2. PMID 26691837

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