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

Meiji Seika Pharma

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: trastuzumab; Drug: DMB-3111

Study type: Interventional

Funder types: Industry

Identifiers

NCT02100917

DMB-3111-2

JapicCTI-142486 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 70 patients

Sex: Male

Ages: 20 to 39 years old

Volunteers: 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

Trial design

70 participants in 2 patient groups

DMB-3111

Experimental group

Description:

6 mg/kg is once given in intravenous drip infusion taking 90 min

Treatment:

Drug: DMB-3111

trastuzumab

Active Comparator group

Description:

6 mg/kg is once given in intravenous drip infusion taking 90 min

Treatment:

Drug: trastuzumab