NCT02100917

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 10, 2015

Status Verified

February 1, 2015

Enrollment Period

4 months

First QC Date

March 27, 2014

Last Update Submit

February 9, 2015

Conditions

Healthy Volunteer

Keywords

BioequivalenceBiosimilaritySimilarityPharmacokineticsPhase ITrastuzumabHealthy Male VolunteersSingle-doseHER-2Oncology

Outcome Measures

Primary Outcomes (2)

  • Area Under the Concentration-Time (AUC)

    Day1-71

  • Maximum observed serum concentration (Cmax)

    Day1-71

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Other Outcomes (1)

  • Incidence of anti-trastuzumab antibodies (ADAs)

    Day1-71

Study Arms (2)

DMB-3111

EXPERIMENTAL

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

Drug: DMB-3111

trastuzumab

ACTIVE COMPARATOR

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

Drug: trastuzumab

Interventions

DMB-3111DRUG
DMB-3111
trastuzumabDRUG
trastuzumab

Eligibility Criteria

Age20 Years - 39 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Fukuoka, Fukuoka, Japan

Location

Related Publications (1)

  • 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: 26691837DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Trastuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2014

First Posted

April 1, 2014

Study Start

January 1, 2014

Primary Completion

May 1, 2014

Study Completion

December 1, 2014

Last Updated

February 10, 2015

Record last verified: 2015-02

Locations

JP(1)