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A Comparing Study Between ALT02(Trastuzumab Biosimilar) and Herceptin® in Healthy Subjects

NCT03242239 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2017-08-21

No results posted yet for this study

Summary

The purpose of this study is to compare ALT02 (Trastuzumab biosimilar) and Herceptin® (US-licensed Trastuzumab and EU-licensed Trastuzumab) in healthy male subjects about the pharmacokinetics, safety, tolerability and immunogenicity.

Conditions

  • Healthy

Interventions

BIOLOGICAL

ALT02

BIOLOGICAL

EU-licensed Herceptin

BIOLOGICAL

US-licensed Herceptin

Sponsors & Collaborators

  • Cristália Produtos Químicos Farmacêuticos Ltda.

    collaborator INDUSTRY

  • Alteogen, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-09
Primary Completion
2016-08-04
Completion
2016-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03242239 on ClinicalTrials.gov