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Clinical Trial of Comparative Study of GB221 Pharmacokinetics

NCT04175171 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-12-18

No results posted yet for this study

Summary

The primary objective is to assess the safety of a single dose of GB221 compared to Herceptin® when administered as a single IV injection at a dose of 8 mg/kg. The secondary objective of the study is to assess the pharmacokinetics of GB221 compared to Herceptin®.

Conditions

Interventions

DRUG

Coprelotamab Injection

The single intravenous infusion of 8mg/kg Coprelotamab shall be administered within 90 minutes through infusion pump.

DRUG

Trastuzumab Injection

The single intravenous infusion of 8mg/kgTrastuzumab shall be administered within 90 minutes through infusion pump.

Sponsors & Collaborators

  • Genor Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Andrewn Redfer, PhD; MBBS · Linear Clinical Research Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-11-07
Primary Completion
2012-01-08
Completion
2012-03-08

Countries

  • Australia

Study Locations

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Entities

Diseases

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 NCT04175171 on ClinicalTrials.gov