NCT02665637

Brief Summary

This is a double-blind, two-arm, parallel-group, single-dose 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 healthy-volunteers

Timeline
Completed

Started Dec 2015

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

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

August 26, 2016

Status Verified

August 1, 2016

Enrollment Period

4 months

First QC Date

January 12, 2016

Last Update Submit

August 24, 2016

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics will be assessed by AUC

    Pharmacokinetics will be assessed by AUC.

    up to week 10

Study Arms (2)

CT-P6

ACTIVE COMPARATOR

Trastuzumab

Drug: Trastuzumab

US-licensed Herceptin

ACTIVE COMPARATOR

Trastuzumab

Drug: Trastuzumab

Interventions

TrastuzumabDRUG

Each patient may receive single dose by intravenous infusion

CT-P6US-licensed Herceptin

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subject
  • Subject voluntarily agrees to participate in this study

You may not qualify if:

  • Female.
  • Subject has a medical condition of disease including one or more.
  • Smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PPD Phase I Clinic

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

Trastuzumab

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Rebecca Wood-Horrall, MD

    PPD Phase I Clinic

    PRINCIPAL INVESTIGATOR

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

January 12, 2016

First Posted

January 28, 2016

Study Start

December 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

August 26, 2016

Record last verified: 2016-08

Locations

US(1)